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Model Number DSX500H11C |
Device Problems
Contamination (1120); Degraded (1153)
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Patient Problems
Dry Eye(s) (1814); Dyspnea (1816); Headache (1880); Excessive Tear Production (2235); Cough (4457); Unspecified Eye / Vision Problem (4471)
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Event Date 10/21/2021 |
Event Type
malfunction
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Event Description
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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 received information alleging an issue related to a cpap device's sound abatement foam.The patient has alleged to having headaches, watery eyes, dry matter in the corner of the eyes, dry eyes, cough and difficulty breathing.There was no report of 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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Manufacturer Narrative
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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 an issue related to a cpap device's sound abatement foam.The patient has alleged to having headaches, watery eyes, dry matter in the corner of the eyes, dry eyes, cough and difficulty breathing.There was no report of serious patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.An internal visual inspection of the device was completed by the manufacturer and found evidence of water ingress on the blower and blower box.The manufacturer found evidence of dust/dirt contamination in the air inlet, throughout the airpath, on the blower box, and on the motor casing/impellers.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 the contaminates found were consistent with water ingress and dust/dirt contaminant, contamination inconsistent with the sound abatement foam.The manufacturer confirmed there was no evidence of sound abatement foam degradation/breakdown.
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Search Alerts/Recalls
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