Model Number UHI-4 |
Device Problem
Failure to Power Up (1476)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The device in this report has not been returned to olympus medical systems corp.(omsc) for evaluation.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.
|
|
Event Description
|
The device suddenly shut down during a procedure.This problem happened twice in the procedure.There was no report of patient injury associated with this event.The user facility did not provide other detailed information.
|
|
Manufacturer Narrative
|
This supplemental report is being submitted to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacture history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, based upon the past similar cases, there was the possibility that the reported phenomenon was attributed to the following causes.-the electrical circuit board of the subject device was accidentally failure.
|
|
Search Alerts/Recalls
|