Catalog Number BLACKMAX-N_LL |
Device Problem
Air Leak (1008)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/11/2014 |
Event Type
malfunction
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Event Description
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It was reported that during pre-surgery, it was observed that the motor device had an air leak.There were no delays to the planned surgical procedure as an identical spare device was available for use.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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Additional narrative: the actual device was returned and is currently pending evaluation.Once reliability engineering evaluates the device, a follow-up medwatch will be submitted.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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Manufacturer Narrative
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The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the outer hose was disconnected from the pressure release valve.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to excessive force on the hose, which was misuse and/or abuse.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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