Model Number CV-180 |
Device Problem
Failure to Power Up (1476)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device in this report has not been returned to 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 maintenance of the device, the switch button of the front panel was not working.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.Aging deterioration may have caused the defect because over 10 years have passed since the device was manufactured.If additional information becomes available, this report will be supplemented.
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Search Alerts/Recalls
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