RESPIRONICS, INC. DREAMSTATION BIPAP AUTOSV H/C, DS; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Model Number DSX900H11C |
Device Problems
Degraded (1153); Failure to Power Up (1476)
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Patient Problems
Epistaxis (4458); Unspecified Respiratory Problem (4464)
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Event Date 10/28/2021 |
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 devices.The patient has been getting a bloody nose, nasal/throat irritation or soreness when he uses the cpap and the device is leaking air.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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Not returned.
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Manufacturer Narrative
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The manufacturer was previously contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap devices.The patient has been getting a bloody nose, nasal/throat irritation or soreness when he uses the cpap and the device is leaking air.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.Corrections has been made as follows: section b5 and section h problem code added.In the original report the customer complaint that the device will not turn on/device not functioning.
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Search Alerts/Recalls
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