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 from the patient alleging that on using the machine the ears of the patient hurt and clog and also sometimes the patient cannot hear.The patient also alleged that the device is too hot to touch.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device has not been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.
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