The manufacturer previously receiving information alleging an issue related to a bipap device's sound abatement foam.The patient allegedly had congestive heart failure, chronic kidney disease and expired.The manufacturer did not receive contact information to obtain additional information and to request the return of the device.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
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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 an issue related to a bipap device's sound abatement foam.The patient allegedly had congestive heart failure, chronic kidney disease and expired.Additional information was received and added to the report.The device was returned to the product investigation laboratory on (b)(6) 2023 for further evaluation.The device was evaluated on (b)(6) 2023.The device was evaluated.The internal and external aspect of the device was inspected.During the investigation, the manufacturer confirms the presence of contamination in the airpath.The unknown dust/dirt contamination found on the blower casing/impeller, blower box, and interior bottom enclosure was inconsistent with degraded sound abatement foam contamination.Evidence of sound abatement foam degradation/breakdown was not observed in the base unit.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the manufacturer.There were no errors found.The manufacturer concludes that they could not confirm the customer's allegation and there was no visible foam degradation but manufacturer did observe dust/dirt contamination in the airpath, likely from a source external to the device.
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