RESPIRONICS, INC. DREAMSTATION BIPAP AVAPS30; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Model Number DSX1130T11C |
Device Problem
Degraded (1153)
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Patient Problems
Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Cough (4457)
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Event Date 08/05/2021 |
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 bipap device's sound abatement foam.The patient has alleged breathing issue, allergie, cough.There was no report of serious patient harm or injury.There was no medical intervention required by the patient.
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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 breathing issue, allergie, cough,particles in tubing/chamber,particles in the water chamber 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 an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.
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Search Alerts/Recalls
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