Model Number UHI-4 |
Device Problem
Application Program Problem (2880)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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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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During the preparation for use, an error was displayed.The details of the error are unknown.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.Omsc surmised that this phenomenon attributed to the broken led of the front panel unit.If additional information becomes available, this report will be supplemented.
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Search Alerts/Recalls
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