RESPIRONICS, INC. DREAMSTATION AUTO BIPAP W/HUM/CELL, DOM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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Model Number DSX700H11C |
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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Manufacturer Narrative
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H3 other text : analysis by third- party.
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Event Description
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The manufacturer received information regarding a dreamstation auto cpap device.The device was returned to a third party service center.During visual inspection of the device, corrosion was found on the power connector.In addition, the inspection found visualization of foam particles and the device was routed to scrap.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.
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Manufacturer Narrative
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The manufacturer received information in relation to a dreamstation auto bipap 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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