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 nasal/throat soreness and developed ulcers while using the device.Medical intervention was not specified.The device was scrapped and cannot be returned to the manufacturer for evaluation and investigation.No other information has been received however if additional information is received a supplemental/follow up will be sent.
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The manufacturer was previously 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 nasal/throat soreness and developed ulcers while using the device.Medical intervention was not specified.The device was returned to the manufacturer's quality product investigation laboratory for further investigation, in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.An internal investigation was performed on the device.The manufacturer confirmed the device had no evidence of foam degradation.The manufacturer found evidence of a faulty pca.The device was scrapped.At this time, no further investigation can be performed.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.
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