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 copd and sleep apnea."patient also reported that his mom died of cancer, and he is afraid that the same will happen to him".Medical intervention was not specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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The manufacturer previously reported information 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 copd and sleep apnea."patient also reported that his mom died of cancer, and he is afraid that the same will happen to him".Medical intervention was not specified.This report was reassessed by the clinical expert team, and it is determined that based on information available at the time of this review, there is insufficient evidence to pronounce a serious injury, as defined in pepf 16.2.8.3 and 21 cfr 803.3(w).The device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.Box b: adverse event/product problem is now updated to product problem.Section h6 coding updated.
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