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Model Number DSX1030T11C |
Device Problem
Degraded (1153)
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Patient Problems
Apnea (1720); Rash (2033)
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Event Date 09/10/2021 |
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 sleep apnea, rash in eyes.There was no report of seriuos 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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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 sleep apnea, rash in eyes 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.
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Manufacturer Narrative
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The manufacturer previously reported on this device in mdr 2518422-2021-06211.This report was submitted as a duplicate report of the previously submitted report.
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Search Alerts/Recalls
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