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Model Number FRX500S14 |
Device Problem
Corroded (1131)
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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 third party service technician.
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Event Description
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The manufacturer received information regarding a dreamstation 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.In addition, the inspection found foam particles are not visible.The unit can¿t be powered on in order to collect the error log/machine hours/error code numbers/software version.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.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
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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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