RESPIRONICS, INC. DREAMSTATION BIPAP AVAPS30 H/HT/C, DS; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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Model Number DSX1130T11C |
Device Problems
Corroded (1131); Complete Loss of Power (4015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/04/2023 |
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.There is no allegation of serious or permanent harm or injury.There was no medical intervention sought by the patient.A device was returned to the manufacturer for evaluation to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.During the evaluation of the device, the third-party service center visually inspected the device and has no visualization of foam particles.There is a corrosion in the device and the connector was completely destroyed.The device was routed to scrap.
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Manufacturer Narrative
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H3 other text : analysis by third- party.
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Manufacturer Narrative
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The manufacturer received information in relation to a dreamstation bipap avaps30.The device was returned to a third-party service center.During visual inspection of the device, it was determined the device was corroded also connector oxide was observed.Device was scrapped at customer's request.Analysis of past events has not indicated an adverse event has occurred due to corrosion.Review of the risk file indicates the potential for a serious adverse event occurring as a result of this incident is unlikely.Additionally, the risk file indicates that corrosion will not substantially affect the performance of the device.This complaint is considered not reportable.
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Search Alerts/Recalls
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