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); Swelling/ Edema (4577); Insufficient Information (4580)
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Event Date 06/07/2021 |
Event Type
Injury
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Event Description
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The manufacturer received a voluntary medwatch (mw5104620) alleging a continuous positive airway pressure (bipap) device's sound abatement foam became degraded.The patient alleged having cancer.The patient also alleged taking synthrioid, lasix, dorzolamide hcl, laianoprost.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 received a voluntary medwatch (mw5104620) alleging a continuous positive airway pressure (bipap) device's sound abatement foam became degraded.The patient alleged having cancer.The patient also alleged taking synthrioid, lasix, dorzolamide hcl, laianoprost.The manufacturer received new information alleging leg swelling, heart and lung issues.
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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 a bipap device's sound abatement foam became degraded and the patient alleged having cancer.The patient also alleged taking synthroid,lasix,dorzolamide hcl,laianoprost.The patient did not report to receive medical intervention.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.
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