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Model Number DSX700T11C |
Device Problem
Degraded (1153)
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Patient Problem
Swelling/ Edema (4577)
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Event Date 02/23/2022 |
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 eye swelling.There was no report of serious 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 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 alleged eye swelling related to a cpap device's sound abatement foam.There was no report of serious patient harm or injury.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.
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Manufacturer Narrative
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Section d1 was corrected from philips cpap to bipap, d4 and h4 were corrected in this report.Section b5 and h10 has been corrected and should be reported as: the manufacturer previously received information alleged eye swelling related to a bipap device's sound abatement foam.There was no report of serious or permanent patient harm or injury.
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Search Alerts/Recalls
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