RESPIRONICS, INC. DREAMSTATION BIPAP AUTOSV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Model Number DSX900T11C |
Device Problem
Degraded (1153)
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Patient Problems
Cancer (3262); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/06/2023 |
Event Type
Injury
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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 bipap device's sound abatement foam.The patient has alleged patient harm.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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This report was previously reported as product problem.After pms evaluation, this report is updated as serious injury."type of reported complaint", "patient outcome code grid (1)", "health impact grid (1)" section has been updated/corrected.Also, this device has returned to the manufacturer and available for evaluation.
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Search Alerts/Recalls
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