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 to experiencing a runny nose, sneezing and alleges that a piece of foam/plastic came loose from the nose/nasal cavity.There was no report of serious patient harm or injury.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 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 to experiencing a runny nose, sneezing and alleges that a piece of foam/plastic came loose from the nose/nasal cavity.There was no report of serious patient harm or injury.There was no medical intervention required by the patient.The device was returned to an authorized service center for evaluation.The device was visually inspected.The service center found no contamination.The device passed all final test.In this report, section d9, g3, h3, h6 has been updated or corrected.
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