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Model Number DSX500H11C |
Device Problem
Corroded (1131)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/22/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H3 other text : device evaluated by third party service center.
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Event Description
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The manufacturer received information in relation to a dreamstation auto cpap.There was no report of serious or permanent harm or injury.During evaluation of the device at a third-party service center, the device destroyed power connector.Corrosion in dc insert.No evidence of foam particles.Contamination finding connector oxide.The device was scrapped.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be file.
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Manufacturer Narrative
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The manufacturer received information in relation to a dreamstation auto cpap 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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