Catalog Number 0279401200 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported that the device was continuously activating.
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Manufacturer Narrative
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Alleged failure: continuous activation.All probes have a default power setting that is not the max power level of the console.The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported that the device was continuously activating.
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Search Alerts/Recalls
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