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Catalog Number EMAX2 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/27/2015 |
Event Type
malfunction
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Manufacturer Narrative
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As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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This is report 1 of 2 of the same event.It was reported that during cleaning/testing, it was observed that the motor device would not stop running until it was unplugged from the console device while in use with hand control device.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Manufacturer Narrative
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The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was not confirmed.An assessment was performed on the device which determined the unit met all manufacture's specifications.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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