Medical Device Safety and Recalls: Dräger Medical Inc., Evita V500 and Babylog VN500 Ventilators with Optional PS500 Power Supply Units - Battery Depletion

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Title: Medical Device Safety and Recalls: Dräger Medical Inc., Evita V500 and Babylog VN500 Ventilators with Optional PS500 Power Supply Units - Battery Depletion

A recall has been issued for the Dräger Medical Inc. Evita V500 and Babylog VN500 Ventilators with Optional PS500 Power Supply Units due to battery depletion.  The firm identified instances when the battery installed in the optional PS500 power supply unit depleted faster than expected and the device shut down even though the visual indicator showed a sufficient charge. Additionally, malfunctions of the battery depletion alarms occurred and they were not consistently triggered when the remaining battery capacity fell below a specific threshold. The company has not received any patient injury reports due to this issue. However, the use of products affected by this recall may cause serious adverse health consequences, including death.  For more information, please see http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm391562.htm


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