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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 : evaluated by third party.
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Event Description
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The manufacturer received information regarding a dream station auto cpap.The device was returned to a third-party service center.During visual inspection of the device, corrosion was found on the power connector and device.In addition, scratches out of spec in upper enclosure.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.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.
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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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