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 04/24/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The subject 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 preparation for use, the user could not turn on the subject device.The user stopped using and replaced the subject device with a similar device.There were no reports of patient injuries related to this incident.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc), therefore omsc cannot investigate the subject device.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.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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