Recall Class: Class I
Date Recall Initiated: February 7, 2014
Products: Evita V500 and Babylog VN500 Ventilators, all lots equipped with the optional PS500 power supply units.
Affected products were manufactured and distributed from June 1, 2011 through January 31, 2014.
Use: The Evita V500 and Babylog VN500 Ventilators for adult, pediatric, and neonatal patients include modes for mandatory ventilation and for spontaneous breathing support and airway monitoring. They are intended for stationary use in hospitals or for patient transport within hospitals
Dräger Medical, Inc.
3135 Quarry Road
Telford, Pennsylvania 18969
Reason for Recall:
The firm identified instances when the battery installed in the optional PS500 power supply unit depleted faster than expected and the device shut down even though the visual indicator showed a sufficient charge. Additionally, malfunctions of the battery depletion alarms occurred and they were not consistently triggered when the remaining battery capacity fell below a specific threshold.
The company has not received any patient injury reports due to this issue. However, the use of products affected by this recall may cause serious adverse health consequences, including death.
Public Contact: See below.
FDA District: Philadelphia District Office
More Information about this Recall:
Dräger sent their customers an Urgent Medical Device Recall letter dated February 2014. The letter identified the product, the problem, and interim action to be taken by the customer until a permanent solution is available.
As an interim solution, the batteries in the PS500 will be replaced free of charge. Dräger service representatives are contacting customers to schedule replacement of the PS500 batteries. Until the batteries are exchanged, Dräger recommends that the user:
- Use an affected device for patient transport only if absolutely necessary.
- Not rely on the battery charge status indicator.
- Always supervise the patient and the ventilator during transport. Ensure that a manual resuscitator is available for manual ventilation, as recommended in the Instructions for Use.
- If the power fail alarm occurs during transport, immediately provide manual ventilation and connect ventilator to a wall power source to resume ventilation.
After the above mentioned battery exchange, Dräger recommends the following:
- Minimize battery usage.
- Avoid brief usage and charging of the PS500 (1-20 minutes)
- Avoid patient transport lasting longer than one hour.
- Make sure to charge the batteries for at least 24 hours.
The exchange of the existing batteries and the above recommendations are only a temporary solution to ensure a minimum operating time of 1 hour independent from the main AC power.
The permanent solution, once available, will also be provided free of charge.
The Urgent Medical Device Recall letter should be distributed to users of the Evita V500 and/or Babylog VN500 Ventilators to make them aware of this device behavior and risk mitigation measures.
For questions regarding the operation and/or servicing of affected Dräger ventilators in the United States, call Dräger Service Technical Support at 1-800-543-5047 (press 4 at the prompt) between the hours of 8 AM to 8 PM Eastern Standard Time, Monday through Friday, or contact Dräger by email at email@example.com .
About Class I Recalls:
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.