Pennsylvania device maker Draeger Medical recalled a pair of its ventilators after discovering battery issues that could put patient safety at risk.
FDA regulators gave the recall their highest-risk Class I label, warning that an unexpected lapse in ventilation could result in patient injury or death. There have been no reports yet of any patient harm, the agency noted.
Draeger discovered the defect through an internal investigation following customer complaints about rapid power depletion in the optional PS500 power unit accompanying certain Evita V500 and Babylog VN500 ventilators.
The batteries installed in the units may suddenly fail without triggering alarms or indicating a low power supply. There may be no indication of a diminished battery until the power’s completely out, Draeger said.
The company issued an urgent notice last month, asking healthcare providers to avoid the affected units when possible and to keep a close eye on patients when the device is relying on the optional power supply, such as during transport.
Draeger is sending hospitals new power units, but that’s just a stop-gap measure. The company is working with suppliers to provide a permanent solution, according to the warning letter.
"The investigation is ongoing and a permanent solution is being investigated, designed, and qualified," according to a press release. "As an interim solution, the batteries in the PS500 will be replaced free of charge."