Model Number UHI-4 |
Device Problem
Unexpected Shutdown (4019)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Olympus inspected the device at the service department of olympus (b)(4) and found followings; the reported event was reproduced.From the log file, the problem of e03 due to a defect in the circuit board was found.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
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Event Description
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A customer reported that when the customer turned on the device, the device made a noise and shut down automatically.Reportedly, an error e03 occurred and the display light on the device was not lit.This event was found during preventive maintenance and did not occur during the procedure.There was no report of patient injury associated with this event.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.No defects other than those reported in the initial mdr were identified by olympus device inspection.Device history record review indicates that the device was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The exact cause of the reported event could not be conclusively determined.However, based on the reported phenomenon, omsc assumed that the reported events were caused by failure of the pressure sensor mounted on the main circuit board.The defect of the pressure sensor may have been caused by peeling-off of wiring inside the pressure sensor due to either of the followings process error.Oxygen entered the device and the electrode of the pressure sensor was oxidized and corroded.Foreign matter (epoxy) had adhered to the pressure sensor due to mismounting the component.If significant additional information is received, this report will be supplemented.
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Search Alerts/Recalls
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