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 02/10/2014 |
Event Type
malfunction
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Event Description
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It was reported that during testing conducted at the manufacturer 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 inspection, a quality engineer did not find any external damage on the cable; therefore, the bias current error alone is an indication the cable¿s internal wiring had become damaged.The device was discarded by the manufacturer.
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Event Description
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It was reported that during testing conducted at the manufacturer 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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Search Alerts/Recalls
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