The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging device will not turn on/device not functioning, unspecified thermal issue and unspecified harm/injury.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device was returned for evaluation.The evaluation has not begun.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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