RESPIRONICS, INC. DREAMSTATION BIPAP AUTOSV, DS; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Model Number DSX900S11 |
Device Problems
Corroded (1131); Power Problem (3010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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.No medical intervention was required by the patient.During the evaluation of the device, the third-party service center visually inspected the device and has no visualization of foam particles.In addition to above findings, the power connector of the unit is corroded and the device was verified that the power source was not connected.The device was routed to scrap.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
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Manufacturer Narrative
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The manufacturer received information in relation to a dreamstation bipap autosv unit.The device was returned to a third party service center.During visual inspection of the device, it was determined the power connector of the unit was corroded.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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