Date Issued: October 19, 2009
Audiences: Health Care Professionals, Patients/Caregivers Using Medical Devices in the Home, Medical Device Manufacturers
Certain medical device AC power cords equipped with a plug that has a prong and ground-pin insert design and a black plastic bridge connecting the terminal prongs on the plug (see Figure 1). Medical device power cords that do not have a black bridge connecting the terminal prongs on the plug are not affected (see Figure 2)
SUMMARY OF PROBLEM AND SCOPE
FDA is investigating whether certain types of power cords used with medical devices may be defective.
Two medical device manufacturers (Hospira, Inc. and Abbott Nutrition) have sent FDA 122 reports of sparking, charring, and fires from the power cords used with their devices. The companies' investigations of these reports determined that the power cord's prongs may crack and fail at/or inside the plug.
The potential risks from this power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires. Depending on the device and therapy, these failures may potentially lead to serious adverse health consequences, including death.
All the reports received so far from Hospira and Abbott have involved AC power cords with the black plastic bridge (see Fig. 1 above) manufactured by the Electri-cord Manufacturing Company. Hospira have voluntarily recalled devices with the affected power cords and are making appropriate replacements for existing customers.
FDA is aware that Electri-cord has supplied the affected power cords to other medical device manufacturers. The agency is now attempting to determine which devices may be equipped with these cords, because theycould pose the same potential risk of electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires.
For Device Users
While further investigation into this matter continues, FDA recommends that all users of medical devices, either in healthcare facilities or in the home, closely monitor the wear and tear on the electric cords used to power these devices. This vigilance is especially important in oxygen rich environments, in which electrical sparking and arcing may trigger a fire.
If you have a medical device that uses a power cord with a black plastic bridge (see Fig. 1) and notice that it has bent or cracked prongs, an outer sheath that is visibly burnt, a black residue, or signs of excessive wear and tear, take the following actions:
- Have a contingency plan to prevent any disruption of patient care.
- Stop using the device with the affected power cord as soon as possible, without jeopardizing patient care.
- Contact the medical device manufacturer or sales representative to report the power cord failure and to request the appropriate replacement/repair.
- Submit a report to the Food and Drug Administration as stated in the “Reporting Problems” section below.
Personnel in healthcare facilities should follow protocols for handling equipment malfunctions as required by their facilities.
For Medical Device Manufacturers
If you manufacture a device with a power cord manufactured by Electri-Cord, or if you have received complaints of device malfunction associated with sparking, charring, or fires from the power cords please:
- Evaluate your medical device to determine whether the power cord is the source of any problems associated with sparking, charring or fires.
- Report events to FDA on FDA Form 3500A, for any complaints that meet the requirements stated in 21 CFR, Part 803 “Medical Device Reporting.”
- Perform the appropriate voluntary correction and/or removal action as stated in the requirements under 21 CFR, Part 806, “Reports of Corrections and Removals.”
FDA is continuing to investigate this problem and will provide additional information as it becomes available.
For more information from Hospira, Inc. and Abbott Nutrition regarding cord replacement please call the numbers below.
|Manufacturer||Recall Information||Contact Information|
|Hospira, Inc.||August 14, 2009|
Urgent Device Recall for AC Power Cords
|1-800-615-0187 (available between 6:00 a.m. and 4:00 p.m. PST)|
|Abbott Nutrition||September 4, 2009|
Urgent Device Recall for Flexiflo® Quantum Enteral Pump
|1-877-457-0249 (available between 8:30 a.m. and 5:00 p.m. EST)|
HOW TO REPORT PROBLEMS TO THE FDA
For Health Care Professionals and Home Users of Medical Devices
If the AC power cord on your medical device shows signs of sparking, charring or fires, we urge you to file a voluntary report electronically with MedWatch, the FDA Safety Information and Adverse Event Reporting program (OMB Approval No. 0910-0291), or you can report directly to MedWatch by phone at 1-800-FDA-1088, or obtain the fillable form online at https://www.accessdata.fda.gov /scripts/medwatch/, print it out and fax to 1-800-FDA-0178 or mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787. Include the brand name, manufacturer, and model number of the device that has the defective power cord as part of the report. Healthcare professionals employed by a facility that is subject to FDA's user facility reporting requirements should follow the reporting procedures established by the facility.
For User Facilities
FDA requires hospitals and other facilities to report deaths and serious injuries associated with the use of medical devices. If a user facility suspects that a reportable adverse event was related to the use of a defective power cord, they should follow the reporting procedure established by their facility. Mandatory reporting requirements for user facilities are found in 21 CFR, Part 803 “Medical Device Reporting.”
For Medical Device Manufacturers
In accordance with the Medical Device Reporting (MDR) regulation, 21 CFR 803.50, FDA requires manufacturers to submit to us, within thirty calendar days of becoming aware, all reportable events involving a device that:
- has or may have caused or contributed to a death, serious injury, or
- has malfunctioned, and the malfunction of the device or a similar device would be likely to cause or contribute to a death or serious injury if it were to recur.
All reports will help us gather additional information related to this problem and assess its public health impact.
If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@CDRH.FDA.GOV or 800-638-2041.
This document reflects FDA's current analysis of available information, in keeping with our commitment to inform the public about ongoing safety reviews of medical devices. The nature, magnitude and possible public health impact of this situation are not yet clear.