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 Problems
Autoimmune Disorder (1732); Cardiac Arrest (1762); Chest Pain (1776); Dyspnea (1816); Emotional Changes (1831)
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Event Date 06/20/2022 |
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 bipap and mechanical ventilator devices.The manufacturer received information alleging difficulty breathing/short of breath, stress test, heart pain, 3 times hospitalized, got heart attack and was diagnosed with graves disease and sleep disorder.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 difficulty breathing/short of breath, stress test, heart pain, 3 times hospitalized, got heart attack and was diagnosed with graves disease and sleep disorder.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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