Catalog Number 0400655000 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/16/2014 |
Event Type
malfunction
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Event Description
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It was reported that during charging at the user facility the device was overheating.No medical intervention and no adverse consequences were reported with this event.As this event occurred during charging, there was no patient involvement and no delay to a surgical procedure.
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Event Description
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It was reported that during charging at the user facility, the device was overheating.No medical intervention and no adverse consequences were reported with this event.As this event occurred during charging, there was no patient involvement and no delay to a surgical procedure.
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Manufacturer Narrative
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The reported overheating was not able to be duplicated by a manufacturer repair technician through functional evaluation.Upon disassembly for visual examination, no components were identified which would have likely caused or contributed to the reported failure.The device was serviced for preventive maintenance, and returned to the user facility.
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Manufacturer Narrative
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Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.
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Search Alerts/Recalls
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