The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- EV1000 Clinical Platform, EV100 Clinical Platform NI, EV100 Clinical Platform CS
- Model Numbers: EV1000A, EV1000NI, EV1000CS
- Lot numbers: All lots for models listed
- Distribution Dates: November 5, 2010 to March 4, 2019
- Devices Recalled in the U.S.: 11,000
- Date initiated by firm: March 21, 2019
Edwards Lifesciences EV1000A, EV1000NI, EV1000CS EV100 Clinical Platforms are used to monitor a patient’s blood pressure and pulse during and after surgery.
Reason for Recall
Edwards Lifesciences is recalling EV1000A, EV1000NI, EV1000CS EV100 Clinical Platforms due to the potential for fluids to leak into the AC power outlet on both the EV1000A and the EV1000NI clinical platforms. Use of these products can result in electrical short circuit, which may cause the device to stop working or lead to a fire. This may result in serious injury to patients and health care professionals, including electrical shock, burns, and cardiac arrest, or death. The risk of fire increases in oxygen enriched environments, such as operating rooms and intensive care units.
Who May be Affected
- Hospitals and health care professionals using an EV1000 Clinical Platform, distributed November 5, 2010 to March 4, 2019.
- Patients who are being monitored with an EV1000 Clinical Platform, distributed November 5, 2010 to March 4, 2019.
What to Do
Beginning on March 13, 2019, Edwards LifeSciences sent “Urgent Medical Device Safety Notification” letters informing customers of affected model/lot numbers and advising customers to keep IV fluid bags and other fluids away from the AC power connector to avoid liquids leaking into the electrical components. In addition, Edwards LifeSciences asked customers to follow installation instructions in the operator’s manual and to complete and return the response form enclosed within the notification.
For EV1000A clinical platform installations:
- Confirm compliance of installation configuration with the current requirements documented in the Operator's Manual section EV1000 Power Adapter Mounting Bracket.
- Avoid immersion of the device or its components and do not allow fluid to enter the device (reference is included in the Warning and Caution section of the Operator's Manual).
- The external power supply for the EV1000A should be installed as illustrated in the Operator's Manual (Figure 15-8 EV1000 Power Adapter Bracket and Figure 15-9 EV1000 Power Adapter Bracket included in the Operator's Manual) where the AC cord plugs into the power supply, exactly as shown in the illustrations in the Operators Manual.
- See illustration for set up from the wall outlet to power supply at the bottom of power adapter (3) as per the illustration of figure 15-9.
- Review the EV1000A clinical platform configurations at your site to ensure they are configured as instructed in the Operator's Manual, to minimize the risk of fluid ingress.
For EV1000NI clinical platform installations:
- We have received reports where liquid is dripping on to the unit which may lead to an electrical short circuit leading to a possible fire hazard due to liquid ingress. Unlike the EV1000A, the EV1000NI AC cord inserts horizontally into the unit. Therefore, orientation is not a factor of liquid ingress. However, in case of excessive liquid exposure, the unit may short circuit leading to a possible fire hazard due to liquid ingress at the AC cord.
The notice requested that customers complete the response form enclosed in the “Urgent Medical Device Safety Notification” so that Edward Lifesciences may follow up with any further actions as necessary.
On May 9, 2019, Edwards LifeSciences sent a supplemental customer notification letter informing customers of other potential causes of fire hazards that are under investigation and the additional actions taken to address the issue, including additional device labeling and potential device design changes. Customers were asked to complete and return the response form enclosed within the notification.
Customers with questions, may contact Edwards Customer Service or Tech Support at:
Edwards Lifesciences, LLC
1 Edwards Way
Irvine, CA, 92614-5688
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Health care professionals employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.