RESPIRONICS, INC. BIPAP AUTO BI-FLEX SYSTEM ONE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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Device Problem
Degraded (1153)
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Patient Problems
Fatigue (1849); Headache (1880); High Blood Pressure/ Hypertension (1908); Choking (2464); Low Oxygen Saturation (2477); Sleep Dysfunction (2517)
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Event Date 04/07/2022 |
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 became degraded and caused choking sensation, headaches, difficulty sleeping, fatigue, low oxygen saturations and hypertension.The patient did report to receive medical intervention and saw a physician.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 an issue related to a bipap device's sound abatement foam became degraded and caused choking sensation, headaches, difficulty sleeping, fatigue, low oxygen saturations and hypertension.There was no report of serious or permanent patient harm or injury.There is no customer information hence we cannot reach out to the customer 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 updated report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this report will be filed.
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Search Alerts/Recalls
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