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.Patient alleges difficulty breathing/short of breath, device beeping and having low pressure, alarming noise.The device was returned but not yet evaluated.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.Patient alleges difficulty breathing/short of breath, device beeping and having low pressure, alarming noise.There was no report of serious or permanent patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for evaluation.The external aspect of the device was inspected and the manufacturer observed dust / dirt contamination on the outer surfaces, cracks, and crevices.The manufacturer found a light amount of beige dust or dust contaminant around the outlet port.The internal aspect of the device was inspected, and the manufacturer observed evidence of water ingress in the blower and blower box, suggesting the use of non-distilled water in the humidifier water chamber.The manufacturer also observed evidence of sound abatement foam degradation in the base unit.The manufacturer found 28 instances of continue error e-223 (err_low_pressure_regulation) were logged, suggesting that the device encountered an issue that led to a decrease in pressure but the device passed pressure testing.The manufacturer observed evidence of water ingress in the blower and blower box, suggesting the use of non-distilled water in the humidifier water chamber.Risk tags (er 2229075 v15) associated with this mode of failure include: irrit02, infect01, degrad04, irrit05, underp01.The results of this investigation do not impact the calculated risks.The manufacturer concludes there was evidence of sound abatement foam degradation and dust/dirt contamination, and evidence of water ingress was observed.Section d8, d9, h2, h3 were updated in this report.Section h6 has been updated.
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