Model Number UHI-4 |
Device Problems
Failure to Deliver Energy (1211); Energy Output Problem (1431)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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When the user turned on the device, the device blacked out.The user inspected the device and found the following.The mainboard of the device had a malfunction.The maximum air supply flow was not up to standard, and the pressure reducing valve had a malfunction.There was no report of patient injury associated with this event.The user facility did not provide other detailed information.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.The device was not returned to olympus medical systems corp.(omsc), therefore omsc cannot investigate the device.Device history record review indicates that the product 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.If additional information becomes available, this report will be supplemented.
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Search Alerts/Recalls
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