Catalog Number IMRI-MOTOR |
Device Problems
Air Leak (1008); Device Operates Differently Than Expected (2913)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/18/2014 |
Event Type
malfunction
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Event Description
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It was reported that during engineering evaluation, it was discovered that the motor device had low revolutions per minutes and high air leakage.The event was not related to surgery.There was no patient involvement.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 for evaluation.Reliability engineering evaluated the device and observed that the device had low revolutions per minutes and high air leakage.The assignable root cause was determined to be due to a worn out motor from normal wear over time.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 evaluation was corrected.The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was duplicated and confirmed.The assignable root cause was determined to be due to misuse, abuse and possibly user error.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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Search Alerts/Recalls
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