All lots of Evita V500 and Babylog VN500 Ventilators equipped with the optional PS500 power supply units and manufactured by Dräger Medical Inc. of Telford, Pennsylvania, are being recalled. Dräger Medical 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. Affected products were manufactured and distributed from June 1, 2011, through January 31, 2014.
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.
As an interim solution, the batteries in the PS500 will be replaced free of charge. 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 batteries in the PS500 are replaced, 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 FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall
See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe