Two ventilators manufactured by Drager Medical have a faulty Drager Medical battery, prompting the US Food and Drug Administration to issue a Class I recall. This is the most severe type of recall, indicating that these defective ventilators are likely to cause serious adverse health consequences or death. The device does not accurately indicate when the Drager Replacement Medical Battery is depleted, so the ventilator may run out of power and unexpectedly shut down, even if the indicator light shows that the battery is charged. If this happens, the patient may not receive necessary oxygen, which could result in injury or even death.
The batteries are particularly important because these ventilators may be used away from a power source during patient transport. When the “low battery” and “depleted battery” alarms sound, the device does not indicate how much time is left before the ventilator runs out of power. Dräger says that in the event of a power outage, the Drager Medical battery backup power supply should last for 30 minutes until the ventilator is connected to the main power source. The batteries are part of the PS500 power supply unit and are used in both ventilators to provide continuous respiratory support to the patient. The Evita V500 ventilator is for adults and children, including premature infants. The Babylog VN500 ventilator supports premature infants. All batches are included in the recall of 2,081 devices distributed between June 1, 2011 and June 30, 2015.Dräger Medical plans to replace all faulty
Drager Medical battery. In the meantime, the company advises customers not to rely on the Dräger Medica battery status indicator. If the power failure alarm sounds, the user should perform manual ventilation and immediately connect the ventilator to the main power source. The recalled ventilators should not be used to transport patients. If transport with the device is unavoidable, medical staff should take additional precautions, including charging the device first and letting it run without a patient to determine the Drager Medical batterycapacity.
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