Model Number 0475100000 |
Device Problems
Electrical Shorting (2926); Temperature Problem (3022)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/14/2022 |
Event Type
malfunction
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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.Please note, this did not occur during a procedure.
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Manufacturer Narrative
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Alleged failure: it was reported by the distributor that electric shocked and small explosion comes from the device for the first time power on.Medical grade power cord used.The failure(s) identified in the investigation is consistent with the complaint record.The root cause is the rf board.Ncr was created for the rf board and will be sent back for further analysis.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
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Event Description
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It was reported that there was a thermal event.Please note, this did not occur during a procedure.
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Search Alerts/Recalls
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