The manufacturer was 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 a bilevel positive airway pressure (bipap) device's sound abatement foam became degraded and caused a patient to develop eye issues.The patient required surgery in response to the reported event.In initial report section b5 was incompletely mentioned and the updated section b5 should be- the manufacturer was previously received information alleging of having afib and low heart rate.The device was returned to the manufacturer's product investigation laboratory for investigation.An external visual inspection of the device was completed by the manufacturer and found no evidence of contamination.The manufacturer completed an internal visual inspection.The manufacturer found evidence of contamination in the bottom panel, blower motor as well as in the blower box and filter port as well as on the non-philips filter.The humidifier was returned to the manufacturer's product investigation laboratory for evaluation.The manufacturer found evidence of contamination in the bottom of the humidifier.The manufacturer found no evidence of sound abatement foam degradation /breakdown.The device's downloaded event log was reviewed by the manufacturer and found no errors logged.The device was applied power and the device operated properly.The manufacturer concludes there was no evidence of sound abatement foam degradation or breakdown.
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