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FDA Recalls Defective Ventilator Battery Supply

FDA Recalls Defective Ventilator Battery Supply

April 2, 2014 — Dräger is recalling the PS500 Power Supply Unit used with the Evita V500 and Babylog VN500 ventilators. The device may not indicate a low battery charge, and users may not realize the problem until the batteries are completely depleted. Without battery, mechanical ventilation will stop and manual ventilation is needed until the ventilator is connected to another power source.

Normally, the “Battery Low” or “Battery Depleted” alarm is triggered when there is less than 10% of remaining battery capacity. Instead, the defective battery produces a “power fail” alarm only when the battery is completely depleted.

The problem was discovered during an investigation of sulfation within the battery, which can occur after frequent short-term use of the PS500 battery. When sulfation occurs, the battery has diminished capacity.

The recalled products were sold between June 2011 and January 2014.


Dräger will replace the batteries in the PS500 free of charge. Until the batteries are replaced, users should:

  • Only use the ventilator for patient transport if absolutely necessary.
  • Do no rely on the battery charge status indicator.
  • Supervise patients and ventilator during transport. Make sure you have a manual resuscitator for manual ventilation.
  • If the power failure alarm goes off during transport, immediately provide manual ventilation and connect the ventilator to a wall power source.

In addition, Dräger recommends minimizing battery usage, avoiding brief usage and charging (1-20 minutes), avoiding patient transport lasting longer than 1 hour, and make sure to charge the batteries for at least 24 hours at a time.

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