Catalog Number 5100004000 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/31/2013 |
Event Type
malfunction
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Event Description
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It was reported that during routine maintenance conducted by a manufacturer field service technician at the user facility the tps handpiece cord caused a bias current message to be displayed on the console, signaling a condition occurred in which the device has the potential to run without user activation.It was reported that there was no associated procedure.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
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Manufacturer Narrative
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A follow up report will be filed after the quality investigation has been completed.
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Event Description
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It was reported that during routine maintenance conducted by a manufacturer field service technician at the user facility the tps handpiece cord caused a bias current message to be displayed on the console, signaling a condition occurred in which the device has the potential to run without user activation.It was reported that there was no associated procedure.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
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Manufacturer Narrative
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During the device evaluation, the engineer determined the cable¿s internal wiring was damaged since no other failures were found and a bias current error is an indication of a loss of electrical integrity.The device was discarded by the manufacturer.
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Search Alerts/Recalls
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