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Model Number DSX500H11C |
Device Problems
Corroded (1131); Human-Device Interface Problem (2949)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/02/2024 |
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 auto cpap device.The device was returned to a third-party service center.During visual inspection of the device, corrosion was found on the device.In addition, there was white screen, and the device was scrapped.This report is being submitted for the corrosion was found on the device 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 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 device.In addition, there was white screen, and the device was scrapped.This report is being submitted for the corrosion was found on the device during service.There was no allegation of serious or permanent harm or injury.No medical intervention was required for the patient.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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