Medical Devices

Case Studies

The FDA encourages consumers and health care professionals to report problems they have with their devices while they are using them. This could be anything from an injury or death to a malfunction or near miss with a device while it is being used. Users should report these problems to the FDA so that we can accumulate information on products in our national database and take any action if needed. The reporting number you should use is 1-800-FDA-1088.


Case Study for September 2014: Un-alarming Oximeter
A caretaker awoke and noticed that the patient’s oximeter reading was on a flat line. The caretaker was uncertain whether she slept through the oximeter beeping “low saturation” or not. The patient nasal cannula came out of his nostrils for an unknown amount of time. He passed away after the incident occurred. Within ten days, the manufacturer contacted the caretaker to obtain the equipment.

Case Study for August 2014: Tanning Bed Burn
A tanning bed consumer reported he sustained a severe burn from a brand new home tanning bed which he directly purchased from the manufacturer’s website. He assembled the device without any difficulty. The tanning bed manual consisted of only four simple steps that guided the user through the assembly of the device. To guide the user through the operation of the device, a summary of the instructions was as followed: lift the canopy; lie down on the bench, face up, lower the canopy as close to the body as possible; turn the timer knob clockwise to the desired tanning session time to begin the session; the lamp will turn on immediately; when the timer reaches “0” the lamp will turn off; if you want to stop the session before the time expires, turn the timer back to “0;” raise the canopy by pushing the outer edge. Following these instructions, he set the device’s timer for nine minutes and lowered the device’s canopy to start his first tanning session. During that session, he fell asleep and woke up approximately an hour later to find the tanning lamps still on. The timer failed to turn the lamps off when the allotted time had passed. He described the burn as very deep. He felt some discomfort and pain in his nerves and muscles. After the incident, he contacted the device’s manufacturer but he could not get in touch with any associate at the firm. The president of the company stated that his staff attempted to contact the individual back but they were unable to reach him. The president assured that each device went through quality assurance checks before being shipped. One of those assurance checks included a test on the tanning bed timer. He also promised to further investigate the complaint then provide a cause for the device failure after this investigation would be complete.

Case Study for July 2014: Infant with Implant
An infant was born with a meningocele at the base of her scalp. When the infant was three weeks old, a neurosurgical team repaired the site; at 8 weeks old, her parents brought her back for an additional surgical procedure. Another lump had grown and she showed signs of delayed cognitive development. During the surgical procedure, a valve and catheter were implanted into her head. The infant’s mother stated that after the implant was installed, the infant’s head would occasionally drop to her chest. Seven months after the surgery, the infant was taken to the emergency room because she was wheezing. She was treated at the hospital and sent home. Two days later, she was found dead by the caretaker who stated she walked away for a few minutes and came back to find the infant unresponsive. The results of the primary autopsy showed severe structural defect in the infant’s cerebellum. The doctor did not think the implant was attributed to the infant’s death. However, she planned to get it tested to see if it was still functional.

Case Study for July 2014: Skin Injury Associated with Cold Therapy Device
An individual received a prescription for a cold therapy device following a surgical procedure that occurred earlier this year. During the continuous use of the device, the individual developed a skin injury despite following the guideline on the device. This injury required additional surgical procedures. Unfortunately, the individual will remain permanently disabled.

Case Study for June 2014: Irritation from Menstrual Pad
A female individual bought some menstrual pads which she started using a couple days after purchase. Within an hour, after putting a pad on, she felt an irritation where she had placed the pad. After a few days, she developed some blisters in the exact area the pad was placed. The blisters were painful and prevented her from performing her daily activities. She felt uncomfortable walking, sitting, taking a shower or getting some sleep. During a visit to her gynecologist, she learned that she got a third degree burn from the chemicals contained in the pad. Her doctor prescribed her two medications, one to ease the pain and the other to treat possible bacterial infection from the burn. The individual claimed the signs and symptoms lasted for more than a month. The affected area became numb following the healing process.

Case Study for May 2014: Deteriorating Eyesight
An individual was using a contact solution to clean her contact lenses. When she inserted the clean lens into her eye, she experienced a burning sensation. She quickly removed the lens from her eye and flushed it with water. She had to rush to the emergency room because she was having blurred vision and the pain from her eye was unbearable. At the emergency room, the doctor informed her that her cornea was burned. The cornea is a transparent part of the eye that covers the pupil. She was prescribed a medication to treat the pain and another to treat possible bacterial infection. But, her vision deteriorated despite being treated. She had a follow-up visit to the emergency room then to an ophthalmologist clinic. Unfortunately, the ophthalmologist confirmed that the damage to the eye was permanent.

Case Study for April 2014: Stay Alert around Oxygen Concentrator!
An individual was sleeping when he suddenly awoke to the smell of something burning. To his dismay, he saw his blankets, chair and floor on fire. He quickly carried the blankets and chair outside to prevent any further damage in the house. It was believed that an oxygen concentrator the patient was using caused the fire. Luckily only the blankets, chair, floor and front panel of the concentrator sustained any damage; the individual did not receive any injury. The rest of his home was intact. He did not seek any medical attention nor call the fire department.

Case Study for March 2014: Dangerous Breastfeeding Device
An individual was using her breast pump. She felt a painful sore on her nipple when she was using the nipple shield of her breast device. The sore became an open wound, and, as a result of her injury, she developed a yeast infection. She received an antibiotic to treat it.

Case Study for February 2014: Patient Lift Fall
Two caregivers were attempting to transfer their heavy elderly father from his bed to a chair using a patient lift. The father started swinging his arms and moving around in the lift. The lift then fell over. This caused bruising of the wrist to one of the caregivers and the father injured his arm. The father and caregiver received treatment and were able to continue to use the lift.

Case Study for January 2014: Respiratory Disaster
A mother walked into a room and saw that her son was not breathing after his father put him down for a nap. The mother noticed that the child had pulled out his tracheostomy tube which was still attached to the ventilator circuit. The mother reported that the ventilator was not alarming and only alarmed once she disconnected the tube from the ventilator circuit. The pulse oximeter was not in use at the time as instructed by the physician. Unfortunately, the child died.

Case Study for December 2013: Black Burns
An individual was using a device for muscle pain in his home when he noticed red burns on his chest and back where the electrodes had been placed. The burns were very painful and the next day, they turned black. His shoulder and arm felt weak. The individual believes that the device did not have clear warning labels with regard to using the device. He plans to see a physician.

Case Study for November 2013: Medical Spa Nightmare
An individual had an intense pulsed light treatment at a medical spa to remove a brown spot on her cheek and a few broken capillaries near her nose. After the treatment, the individual’s skin was red and burned for 2 days. The individual later developed open tiny bumps all over her face and an orange peel texture. About two weeks later, she noticed large depressed areas under both cheekbones and on her forehead. Her dermatologist diagnosed it as fat necrosis, which could be due to a machine or operator error. Although there has been improvement due to a round of prednisone, she continues to experience symptoms.

Case Study for October 2013: Uncontrolled Wheelchair
An individual was making a turn onto a ramp in his powered wheelchair when the wheelchair powered off and caused the patient to lose control. The individual rolled down the stairs while in the chair and landed face down. When the paramedics arrived and tried lifting the wheelchair off the individual, the wheelchair powered back on and ended up injuring one of the paramedics. The individual trapped under the wheelchair sustained a possible right knee fracture, chipped tooth, swelling, bruises and aggravation of a previous C4-5 spinal injury. The individual remained bedridden after being released from the hospital 3 days later.

Case Study for September 2013: Pillow Fire
An individual left her heating pad in between two pillows and plugged it in a multi-plug adapter. The individual went to cook something and when she came back to her room, the pillow was on fire. She attempted to extinguish it by carrying the pillow to the bathroom to immerse it in water but the fire spread on her and caused the combustibles in the bathroom to explode. She was taken to the hospital and unfortunately, died 4 days later due to the burns she sustained.

Case Study for August 2013: Camper Blaze
An individual that was in his camper was using an oxygen concentrator to help him breathe. He was also using a space heater to keep himself warm. A fire erupted due to the use of the space heater and oxygen concentrator in close proximity. Unfortunately, the individual was killed in the blaze.

Case Study for July 2013: Jumping Battery
An individual using a portable ECG monitoring device was charging her lithium-ion battery for her device on the kitchen counter. About 45 minutes into charging, she heard a loud popping noise coming from the kitchen. When she went to see what had happened, she discovered her battery nearly 15 feet away from the counter it had been on originally and it was emitting flames. Her son came in and put out the flames by stomping on the battery with his boot. Thankfully, no one was injured however; the kitchen floor was burned where the battery had landed after exploding.

Case Study for June 2013: Compress Explosion
An individual bought a new hot or cold compress. The individual had a pimple behind his ear drum and the individual’s doctor had recommended applying heat to the ear. When the individual picked up the compress to put it in the sleeve, it exploded and caused the hot gel to burn his neck, chest and arms.

Case Study for May 2013: Humidifier Fire
An individual was using a humidifier in their room when it suddenly started emitting flames. The bottom of the humidifier burned the carpet and dresser. Luckily, the individual was not injured.

Case Study for April 2013: Electrical Burn
An individual was using a neuromuscular electrical stimulation device for pain at home. During the third use, the individual felt like her skin was burning. When the individual took off the electrodes, the individual had burns on her skin where the electrodes had been placed.

Case Study for March 2013: CPAP on Fire
An individual was using his CPAP at night when the individual saw flames emitting from the CPAP. Thankfully, the individual was not injured.

Case Study for February 2013: Tragedy with a Tampon
A teenaged female was with her boyfriend when she felt dizzy and could not feel her legs anymore. Her boyfriend called the hospital and she was admitted into the ICU. She had used her tampon for 20 hours. The doctors concluded that she had an abscess on her heart and had developed kidney failure. The family had been notified that she had developed toxic shock syndrome. She passed away due to a brain hemorrhage.

Case Study for January 2013: Scrub explosion

After a purchase of a cleansing and exfoliating system online, the patient used the product for approximately 4-5 weeks. During use, the product suddenly exploded in the patient’s hand and left a ringing in her ear for approximately 30 minutes. The patient reported to experience continued ear pain. The patient went back to inspect the device and observed that something exploded from inside the device and ruptured the rubber exterior buttons to create the loud explosion.

Case Study for December 2012: Night fire

During the night, a patient woke up to his CPAP on fire. He quickly jumped up and unplugged the unit from the wall outlet which extinguished the flame. Unfortunately the patient disposed the device before the manufacturers could inspect the device.

Case Study for November 2012: Fire on the sofa

A patient was sitting on a therapeutic cushion on the sofa while smoking. The sofa suddenly caught fire and the patient screamed for help. Luckily he was on intercom with his caregiver neighbor while this incident begun. She sprinted to his house and tried putting the fire out by wetting a towel and rolling him on the floor. The patient was transferred to a nearby hospital. Thirty percent of his body suffered from severe burns. Unfortunately, the patient died nine days after the fire incident.

Case Study for October 2012: Failed Infusion Pump Alarm
A nine year old girl was using an infusion pump to manage her diabetes. She was using an insulin infusion pump set that was discarded from the hospital. The patient got her catheter changed on the first of June. Soon after, she experienced nausea and vomiting that evening and was sent to the emergency room the next morning. The girl was conscious when she arrived at the hospital. The catheter was immediately removed and medical professionals discovered a bent cannula. The infusion pump never alarmed to inform any changes. The child died the next afternoon due to heart failure.

Case Study for September 2012: Humid fire

A man reported that his humidifier burst into flames after 15 minutes of usage. Luckily the man was not hurt through this incident.

Case Study for August 2012: Allergic instrument

A laboratory employee experienced an allergic reaction when he came in contact with an immunoassay system. He instantly broke out in a rash and experienced respiratory distress due to his severe allergies. He was immediately transported to the hospital and received Epi Pens.

Case Study for July 2012: Cold fine print

A patient was given a reusable instant cold pack when she had surgery and placed it back in the freezer when she was finished with using it. The next morning, she took it out of the freezer to use on her arthritic knee. She didn’t feel a thing when she used it. But when she took of the freeze pack, she noticed that her leg was burned on blistered. She went to the doctor and was informed she got a third degree burn on her knees. She said that when she read “reusable” on the front of the pack, she automatically assumed she should place it in the fridge after use. Unfortunately, she failed to notice the fine print at the bottom of the package that says “Do Not Freeze.”

Case Study for June 2012: Sever Frost Bite
After an outpatient surgery with fusion and deep peroneal nerve burial on the patient’s right foot, he was provided with a cold therapy unit prior to his discharge. He was instructed to use the unit continuously. A few days after, the patient experienced severe pain and chills on his foot and was sent to the emergency room. The medical team tried all sorts of methods to treat his foot, but it was too late. The patient had to have four of his toes and part of his foot amputated.

Case Study for May 2012: Tragedy with Oxygen Therapy
A patient receiving oxygen therapy at home was cooking in the kitchen with his therapy equipment on. Through a series of unexpected events, an explosion erupted in the kitchen and fire spread throughout the house. The patient was killed in the explosion.

Case Study for April 2012: Fire in the bed
An elderly patient was bedridden to a remote control hospital-type bed. Due to electrical wiring complications, a fire was ignited and the patient was stuck in the bed. The patient later suffered from severe burns and died as a result of the fire.

Case Study for February 2012: Cold Burn
A patient was having trouble with her liquid oxygen portable tank. The liquid oxygen tank would freeze the outside of her insulated bag. As a result, the patient suffered from burns that needed to be treated by a plastic surgeon.

Case Study for March 2012: Blackout
A patient’s CPAP machine stopped working completely when his community experienced a blackout due to severe winds. The device had to be removed and the power had to be completely resorted before the device could work again.

Case Study for January 2012: Spontaneous Wheelchair Combustion
After driving his scooter outside, the patient decided to park it on his deck. About a half hour later, the scooter caught on fire. The patient quickly tried to extinguish the fire by pouring water over it. After this event, the patient had to seek medical attention due to an anxiety attack.

Case Study for December 2011: Deadly tampon
The patient was using a regular absorbency tampon, when she went into toxic shock syndrome. She was admitted to the hospital with dehydration, vomiting, fever, and kidney failure. The patient died as a result of adult respiratory distress syndrome, sepsis, rash, and heart failure.

Case Study for November 2011: Burning cramps
A woman was using heat wraps to alleviate menstrual cramps. The patient used these heat wraps for 6 hours, and when they were removed, she noticed two quarter sized red patches on her lower abdomen. These patches began itching and her skin bubbled up. The patient had to treat the patch burns for a month after the incident occurred because it resulted in a 3rd degree burn.

Case Study for October 2011: The deadly alarm
A young patient had a heart monitor that had the ability to alarm his parents when his heart rate was slowing down. In the middle of the night, the monitor alarmed and woke the parents, but the timing was too late. The monitor alarmed when the patient had stopped breathing entirely. Tragically, the young patient passed away.

Case Study for September 2011: Slippery Wheelchair
A Home Health Services Physical Therapist reported that a patient fell while being transferred into and out of her new wheelchair. The patient explained that the wheelchair slid away from her. She noticed that the wheelchair brakes were inadvertently unlocked by the leg rest when she tried to swing them out of her way to sit. Her physical therapist tried to adjust the leg rests into a position that would avoid contact with the brake handle but was unable to. The same problem occurred when a second wheelchair was delivered to the patient. Home Health Services later learned that the push locks on this specific wheelchair could be disengaged by the elevating leg rests when swung completely open. The elevating leg rest could not be moved into a position that would avoid contact with the handle on the push to lock the brakes.

Case Study for August 2011: Strangling Strap
A 5 year-old girl with cerebral palsy was watching TV while sitting strapped into her stroller. The girl had moved from the original upright position in a way that loosened the straps on her chest and pelvis. The girl then proceeded to slip forward in the chair which caused the strap to put pressure on her neck. Her sister discovered her, and observed that the strap was caught around her neck. The young girl was immediately taken to the hospital. Unfortunately, after a series of events, she died one week later.

Case Study for July 2011: Dangerous Purchase
A consumer ordered a knee walker/leg caddy from an online shopping website. This device was unsuitable and even dangerous because the knee platform was unsteady and the pads were slick. The steering did not turn 120 degrees as advertised, the brake did not work well, and the handlebars collapsed (weight was not a factor). As a result, the consumer experienced a fall. At first, the online seller refused a refund, but the buyer appealed to PayPal and PayPal secured a full refund on the basis that the device was unsafe and not as described. The consumer later learned that this device was an imitation to a superior product. This cheaply-made imitation is extremely dangerous and could further injury and/or result in additional surgery for many people. Unfortunately, the imitation is still being sold on the shopping website.

Case Study for June 2011: Poor Integrity Leading to Fall
A patient was being transferred from his hospital bed to the shower using a lift with a sling. While he was being transferred, the gray connector clip on the sling snapped in half, causing the patient to topple to the ground. The nursing staff observed that the sling experienced multiple washings which contributed to the poor integrity of the clip.

Case Study for May 2011: A Powerful Sneeze
While the patient was sneezing, his hand accidently pressed the speed button on his wheelchair. As a result, his power wheelchair shot forward with his arm fully extended. The patient was rammed into his TV and broke the glass door on the TV stand. A physical therapist was present at the event, and noted that the joy stick was close in proximity to the speed button. Due to the placement of the speed button, it was extremely easy to accidently increase the wheelchair speed while operating the joy stick.

Case Study for April 2011: Fatal Feeding
After a power surge that occurred in the morning, a baby’s feeding pump was reset from 30 ml to 300ml/hour feeding rate. It is unclear whether the feeding pump was plugged into an electrical outlet at the time of the power surge. The grandmother noticed the change, yet didn't know what it meant so she continued to feed and input formula until the bag was empty. As a result, the baby was overfed. After the baby had been born, the mother, grandmother, and a Spanish interpreter were taught by the charge nurse on how to use the feeding pump. In fact, they had received teaching sessions 24-48 hours prior to the baby’s initial discharge from the hospital. When they discovered the ill and motionless baby, the mother immediately rushed the baby to the ER. The baby had apparent respiratory ailments. The mother estimated that the pump was running at 300ml per hour for approximately 2 hours. During the check up, it was discovered that the baby was suffering from necrotic bowel situation and a large amount of enteral formula was found in the stomach. As a prior condition, the baby was born with a congenital heart defect. Sadly, the baby died shortly after.

Case Study for March 2011: Roasting Patch
A 70 year old woman started using two pain relieving heat patches to treat her lower back pain. The following day, her husband, daughter, and caregiver noticed redness and burns on the area of her skin where she applied the patch. In response, she applied bacitracin cream to ease the symptoms and stop the burning. The cream did not prove to be effective so she ended up getting hospitalized for burn. The woman was discharged from the hospital five days after the incident. Her skin, where the patch was applied, ended up peeling off her back.

Case Study for February 2011: Hot Seat
A man laid waiting in bed to be transferred into his power wheelchair by his brother. His brother walked over and unplugged the 12 volt charger that was connected to the battery in the base of the chair which provides power to the man’s ventilator. Instantly, a fire erupted from underneath the seating system. The man’s brother, and later, his wife whom rushed to the scene, immediately sprayed the wheelchair with a fire extinguisher, but the fire continued to burn. In quick reaction, the brother and wife detached the backpack and ventilator from the back of the chair and continued to spray it with a fire extinguisher. They had to roll it outside because the bedroom and entryway were full of smoke. The fire continued to last for approximately one minute before dying out.

Case Study for January 2011: Charged Car
A 40 year old father had just had an implantable cardiodefibrillator (ICD) placed in the week before. The ICD was working well and he was not experiencing any problems. After healing for a week, the father decided to play with remote controlled cars with his son. Initially while he was standing and playing with the cars, the father did not sense any problems. However, when the father lay down on the ground and the son started to drive the remote controlled car over his father's chest, the ICD would beep. Even though the son found this funny, the father got up and stopped playing with the remote controlled cars. He reported this to his physician even though he didn't have any further complications.

Page Last Updated: 09/04/2014
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