RESPIRONICS, INC. DREAMSTATION BIPAP AVAPS30; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Model Number DSX1130T11C |
Device Problem
Degraded (1153)
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Patient Problems
Apnea (1720); High Blood Pressure/ Hypertension (1908); Unspecified Heart Problem (4454); Insufficient Information (4580)
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Event Date 02/24/2023 |
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 manufacturer received information alleging an issue related to a bipap device's sound abatement foam.The manufacturer received information alleging of apnea, heart condition, high blood pressure, medical conditions and issues.There was no report of serious or permanent patient harm or injury.There was no medical intervention 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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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, and mechanical ventilator devices.The manufacturer received information alleging an issue related to a bipap device's sound abatement foam.The manufacturer received information alleging of apnea, heart condition, high blood pressure, medical conditions and issues.There was no report of serious or permanent patient harm or injury.There was no medical intervention required by the patient.Despite multiple attempts, the device has not yet returned to the manufacturer for evaluation.At this time, no further investigation can be performed.There has been no response from the customer on the return of the device.If any additional information is received, a follow up report will be filed.In box g, date received by mfr is updated.In box h, evaluation method code grid-evaluation results code grid-conclusion code grid is updated.
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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, and mechanical ventilator devices.The manufacturer received information alleging an issue related to a bipap device's sound abatement foam.The manufacturer received information alleging of apnea, heart condition, high blood pressure, medical conditions and issues.There was no report of serious or permanent patient harm or injury.There was no medical intervention required by the patient.In box h, evaluation results code grid was wrong, which is updated in this follow-up.
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Search Alerts/Recalls
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