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 an issue related to a cpap device's sound abatement foam.The patient has alleged having diagnosed with congestive heart failure.There was no medical intervention required by the patient.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 allegation of an issue related to sound abatement foam.Additional information was received and section b5 should be reported as: 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 previously reported allegation of an issue related to sound abatement foam and became degraded and patient has alleged having diagnosed with congestive heart failure.The medical intervention that the patient received in response to the event is currently unknown.The reported event and its reported severity was reviewed by the manufacture's clinical expert.The event is not related to the device in this case.Based on the available information, the manufacture concludes, no further action is necessary.The device has not yet returned to the manufacturer for evaluation.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.Sections b1, b2 have changed related to the complaint changing from the reported adverse event to a product problem.Section d1 (brand name), d2 (type of device), d4 (additional device information) and h4 (device manufacturer date) were incorrectly reported in the initial report, which was correctly updated in this follow up report.Section h1 has changed to reflect a malfunction.Section h6 health effect- impact code (2199), type of investigation, investigation findings and investigation conclusions has been updated.
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