FDA Recalls Defective Ventilator Battery Supply

FDA Recalls Defective Ventilator Battery SupplyApril 2, 2014 — Dräger has issued a recall for the PS500 Power Supply Unit, an optional battery used with the Evita V500 and Babylog VN500 ventilators, because it may not give users any warning until the batteries are completely empty.

The mechanical ventilator will not work if the batteries are depleted, and caregivers will need to provide manual ventilation to patients until the ventilator is connected to another power source. An interruption in ventilation could increase a patient’s risk of injury or death.

Normally, the “Battery Low” or “Battery Depleted” alarm should go off when the battery is below 10%.However, the PS500 Power Supply Unit produces only a “power fail” alarm when the battery is completely empty.

Dräger discovered the problem while investigating sulfation in the battery, which decreases the battery’s capacity. The capacity may be further diminished after frequent short-term use.

The recalled batteries were sold from June 2011 – January 2014.

What Should I Do?

Contact Dräger for a free replacement battery. Until the battery is replaced, uses should take the following precautions:

  1. Use an affected device for patient transport only if absolutely necessary.
  2. Not rely on the battery charge status indicator.
  3. 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.
  4. If the power failure alarm occurs during transport, immediately provide manual ventilation and connect the ventilator to a wall power source to resume ventilation.

After the above mentioned battery exchange, Dräger recommends the following:

  1. Minimize battery usage.
  2. Avoid brief usage and charging of the PS500 (1 – 20 minutes).
  3. Avoid patient transport lasting longer than 1 hour.
  4. Make sure to charge the batteries for at least 24 hours.

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