Model Number 0475100000 |
Device Problem
Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/28/2023 |
Event Type
malfunction
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Event Description
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It was reported that there was a thermal event.
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
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Event Description
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It was reported that there was a thermal event.
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Manufacturer Narrative
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Alleged failure: e41 error the failure(s) identified in the investigation is consistent with the complaint record.The root cause is the rf board.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
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Search Alerts/Recalls
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