Catalog Number 4208000000 |
Device Problem
Unintended Power Up (1162)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/28/2014 |
Event Type
malfunction
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Event Description
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It was reported that during testing conducted at the user facility, the device was running without user activation.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing, there was no patient involvement and no delay to a surgical procedure.
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Manufacturer Narrative
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The reported unintended activation was confirmed by a manufacturer repair technician through functional evaluation.Upon disassembly, a failed motor controller was found, which can cause the reported event.
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Event Description
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It was reported that during testing conducted at the user facility the device was running without user activation.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing, there was no patient involvement and no delay to a surgical procedure.
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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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