The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.Patient alleged having cancer surgery to remove tumours, headache, sleep apnea.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 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 received information alleging issue related to a cpap device's sound abatement foam.The patient alleged having cancer surgery to remove tumours, headache, sleep apnea.The above reported event is assessed as possibly related to the device in this case.Hence, the device may have cause or contribute to the alleged serious injury.The patient did not report to receive medical intervention.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.
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