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Model Number FRX500S14 |
Device Problems
Corroded (1131); Failure to Power Up (1476)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/21/2023 |
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 auto device.The device was returned to a third-party service center.During visual inspection of the device, corrosion was found on the power connector and on metallic surface of the device.In addition, the inspection found unit can't be power on, contamination from dust/dirt and the device was scrapped.This report is being submitted for the corrosion was found on the power connector and on metallic surface of 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 in relation to a dreamstation auto 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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