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Model Number DS960XHS |
Device Problem
Degraded (1153)
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Patient Problems
Loss of Vision (2139); Vomiting (2144); Eye Burn (2523)
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Event Date 07/09/2021 |
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 eyes burning; unable to see; vomiting.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 alleging eyes burning; unable to see and vomiting related to a bipap device's sound abatement foam.There was no report of 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.Corrction was made in a3 section and h6 section was updated in this report.
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Search Alerts/Recalls
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