RESPIRONICS, INC. DREAMSTATION BIPAP AVAPS; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Model Number DSX1130T11C |
Device Problem
Corroded (1131)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/16/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H3 other text : device serviced by a third-party service center.
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Event Description
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The manufacturer received information regarding a dreamstation bipap avaps.The device was returned to a third-party service center.During visual inspection of the device, it was found that the power connector corroded.Also, the device was scrapped.This report is being submitted for the corrosion found on the power connector during service.There was no allegation of serious or permanent harm or injury.No medical intervention was required for the patient.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 unit.The device was returned to a third party service center.During visual inspection of the device, it was determined the 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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