Evita V500 and Babylog VN500 Ventilators by Dräger Medical: Class I Recall - Faulty Batteries

AUDIENCE: Risk Manager, Surgery, Critical Care Medicine, Nursing, Pediatrics

ISSUE: The battery (part of the PS500 Power Supply Unit) that powers the Evita V500 and Babylog VN500 Ventilators does not last as long as expected. The battery indicator light shows a sufficiently charged battery even when the battery is depleted. When the “battery low” and “battery depleted” alarms sound, the devices do not indicate how much time is left before the ventilator will shut down due to lack of power. Analysis by Dräger indicates that the battery should last approximately 30 minutes. If the power is lost, the 30-minute battery back-up should last until the ventilator is connected to a main power supply. See the Recall Notice for a list of affected lot numbers.

BACKGROUND: The Evita V500 Ventilator provides constant breathing support for adults and children, including premature babies weighing at least 14 ounces. The Babylog VN500 provides constant breathing support for premature babies weighing at least 14 ounces. Both ventilators are used in hospitals or during patient transport.

RECOMMENDATION: In July 2015, Dräger Medical sent an Urgent Medical Device Recall letter to its customers informing them that Dräger Medical plans to replace all faulty batteries. The letter instructed customers to follow these recommendations until the new batteries are installed:

Notify all device users within your facility of this issue.
Do not rely on the battery status indicator
Provide manual ventilation and immediately connect the ventilator to a main power supply, if the power fail alarm sounds.
Do not use the device to transport patients unless necessary
If you need to use the device for patient transport, first determine the battery capacity:
- Charge the battery of your device for at least 24 hours as described in the Instructions for Use
- Let the device run without a patient on battery.
- Determine how much time is remaining on the battery:
  - More than 2 hours: Device may be used for 6 months for patient transports lasting a maximum of 1 hour. Contact Dräeger Service to schedule battery replacement.
  - Less than 2 hours: Do not use the device for patient transport. Contact Dräeger Service for immediate exchange of the battery.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Read the MedWatch safety alert, including a link to the FDA recall notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm460958.htm