Covidien send an alert to authorities in England, Northern Ireland, Scotland and Wales after the company didn’t hear back from users that they had acted on warnings initially sent in April.
Covidien asked users of certain Legendair and Supportair mobile ventilators to acquire and install replacement parts to correct a potential issue in which the device’s internal battery may fail to kick on when the ventilator is disconnected from a main power source.
The affected part is one that should be replaced yearly as part of a standard preventive maintenance schedule, but Covidien recommended immediate replacement for patients who rely on ventilation 16 or more hours per day.
For less dependent patients, the replacement should be conducted during the next scheduled device maintenance, according to documents filed with the U.K.’s Medicines & Healthcare products Regulatory Agency.
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