Model Number UHI-4 |
Device Problems
Failure to Power Up (1476); Complete Loss of Power (4015)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/26/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
The suspect device was sent to an olympus service center for evaluation.During inspection and testing, the report that the device spontaneously powered down could not be duplicated.Inspection and testing found an alarm was activated when the device was powered on due to a faulty main circuit board.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
|
|
Event Description
|
The customer reported the subject device powered off spontaneously.The event occurred during maintenance and there was no patient involvement.The suspect device was sent to an olympus service center for evaluation.During inspection and testing, an alarm was activated when the device was powered on.
|
|
Manufacturer Narrative
|
This report is being supplemented to provide additional information based on the approved final investigation.Section e2, e3, and g2 were corrected with information that was inadvertently omitted from the initial report.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the definitive root causes of the spontaneous power failure and faulty main board could not be determined.Olympus will continue to monitor field performance for this device.
|
|
Search Alerts/Recalls
|