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Dräger Recalls Ventilators over Battery Issues

A Dräger Medical ventilators recall has received a Class I designation from the FDA, the agency reported Thursday.

 

The company has not received any patient injury reports due to the Evita V500 and Babylog VN500 Ventilators, which apparently have optional power supply unit batteries that deplete faster than expected.

FDA officials, though, caution that serious injury or even death could result with the issues around the ventilators. Dräger discovered that the battery issue in some cases could cause the ventilators to shut down even though visual indicators showed a sufficient charge, according to the FDA.

In some cases, neither the "battery low" nor the "battery depleted" alarm was triggered when the remaining battery capacity was below 10%. Dräger elaborated in its own news release. A power fail alarm, though, did go off when the battery was depleted completely.

Battery capacity itself was down due to the occurrence of sulfation within the battery.

The batteries were for the optional PS500 power supply units for the ventilators. As an interim solution, Dräger says the batteries in the PS500 will be replaced free of charge.

The Evita V500 and Babylog VN500 Ventilators are for adult, child, and infant patients, and are for stationary use in hospitals or for patient transport within hospitals.

Affected products were manufactured and distributed from June 1, 2011 through January 31, 2014.

 

This is the third ventilator recall in the past two months to receive Class I status from the FDA. Roughly 600 Philips Respironics Trilogy Ventilators could cause serious injury or death because of a power management board issue that could cause the ventilators to not actually deliver mechanical breaths, and GE Healthcare is recalling a host of infant resuscitators from the past five years because oxygen and air wall inlet fittings on their back panels were reversed during assembly.

 

Source: Qmed

 

 

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