DEPUY SYNTHES POWER TOOLS UNIVERSAL BATTERY CHARGER II; BATTERY, REPLACEMENT, RECHARGEABLE
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Catalog Number 05.001.204 |
Device Problems
Failure to Charge (1085); Corroded (1131); Crack (1135)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/18/2015 |
Event Type
malfunction
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Event Description
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It was reported that during service and repair pre-testing, it was observed that the feet on bottom of the universal battery charger device were cracked.It was further observed that the vent fan was cracked and broken away, bay three was faulty, the red light came on with all battery and power module devices, the device would not charge the battery devices, and had corrosion around contacts in bays one and two on the device.The event was not related to surgery.There was no patient involvement reported.There were no injuries or medical intervention associated with this event.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 has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.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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This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and observed that the housing was damaged, bay 3 did not charge battery devices, and corrosion on contacts in bay 1 and 2.Therefore, the reported condition was duplicated and confirmed.The assignable root cause was determined to be due to improper handling and user error.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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