RESPIRONICS, INC. DREAMSTATION BIPAP AUTOSV H, DS; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Model Number DSX900H11 |
Device Problems
Degraded (1153); Excess Flow or Over-Infusion (1311); Noise, Audible (3273)
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Patient Problems
Sore Throat (2396); Unspecified Respiratory Problem (4464)
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Event Date 11/10/2021 |
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.Patient called in and said that his getting too much air from using his machine.He said he can't stop using it even though he was told by his doctor.Device is noisy, nasal/throat irritation or soreness.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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H3 other text : not returned.
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Search Alerts/Recalls
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