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Catalog Number 05.001.227 |
Device Problems
Leak/Splash (1354); Occlusion Within Device (1423); Difficult to Open or Remove Packaging Material (2922); Protective Measures Problem (3015)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was determined to be due to improper maintenance, which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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Event Description
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It was reported from (b)(6) that during service and evaluation, it was observed that the turning knob on the lid for the battery device was blocked, too tight and leaking.It was further determined that the device failed the following pre-tests: check function of turning knob and check for leakage.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Search Alerts/Recalls
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