RESPIRONICS, INC. DREAMSTATION BIPAP AUTOSV; VENTILATOR, CONTINUOUS, NON-LIFE SUPPORTING
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Model Number DSX900H11C |
Device Problem
Degraded (1153)
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Patient Problem
Hypersensitivity/Allergic reaction (1907)
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Event Date 04/07/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H3 other text : device not returned from manufacturer.
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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 patient alleges having hives from device.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.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 previous reported information 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 patient alleges having hives from device.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.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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Search Alerts/Recalls
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