Model Number UHI-4 |
Device Problem
Electrical /Electronic Property Problem (1198)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 11/30/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
The subject device 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 is received, this report will be supplemented.
|
|
Event Description
|
Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair at olympus china, it was found that the subject device had the power or the front panel issue, also the main board was faulty and the power supply was loose.There was no report of patient injury associated with this event.
|
|
Manufacturer Narrative
|
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 information from olympus china, there was the possibility that the reported phenomenon was attributed to the failure of the main board.
|
|
Search Alerts/Recalls
|