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 manufacturer received information alleging of nasal/throat irritation or soreness, headaches, cough, rash.There was no report of serious or permanent patient harm or injury.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 nasal/throat irritation or soreness, headaches, cough, rash related to a cpap device's sound abatement foam.There was no report of patient harm or injury.After the final attempt to have the device and components returned for evaluation, customer declined to respond to the gfe related questions and terminated the call.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.In the initial report section d1 was wrongly captured, corrected in this report.In the initial report section d4 was missed to capture, corrected in this report.Section h6 updated in this report.
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