October 10, 2014 — CareFusion has issued a recall for EnVe and ReVel ventilators because the power cord adaptors can become damaged, resulting in loss of power and complete shut off.
The EnVe and ReVel ventilators are used to provide mechanical ventilation or respiratory support for patients in the hospital, during transport, or at home. They may be operated using either batteries or an external power source (AC or auto lighters).
CareFusion has received 256 reports of the incident, with no reports of injury or death. However, the FDA has classified the recall as Class I — the most serious type of recall — because shut-off from power failures could lead to serious patient injury or death.
According to the recall:
“The pins of the external power connector did not always align properly with the input port of the ventilator. This misalignment can damage the pins on the connector and possibly short circuit the ventilator. A short circuit in the power supply may prevent the ventilator battery from recharging, and the ventilator could lose power unexpectedly.”
The recall involves products that were manufactured between May 2009 and August 2014. CareFusion notified customers of the recall in August, explained the problem, and corrective actions to be taken. CareFusion said they will send two new power adaptor accessory kits for the ReVel and EnVe ventilators.
- Plug in the new AC Power Adapters and return a confirmation for each one used.
- Identify the ventilator serial numbers and/or serial numbers of AC Power Adapters, and Auto Lighter Power Cords which have been attached.
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