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
Dyspnea (1816); Cough (4457); Unspecified Gastrointestinal Problem (4491)
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Event Date 03/27/2023 |
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 patient alleges he is waking up coughing and also with gassy bubbles in stomach.Patient also alleges difficulty breathing.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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Device not returned.
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Manufacturer Narrative
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The manufacturer previously 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 he is waking up coughing and also with gassy bubbles in stomach.Patient also alleges difficulty breathing.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.On the previously submitted report, the cfn number was incorrect.This follow-up is to report this error.
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Search Alerts/Recalls
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