Model Number 0475100000 |
Device Problem
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 10/15/2022 |
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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Manufacturer Narrative
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The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence. alleged failure: handpiece of the port is burnt.Confirmed failure: circuit board failure.Probable root cause: console fuses fail to break circuit due to excessive mains current leading to fire isolation power supply failure.Use error: console is sterilized or disinfected.Use error: console cleaned with incompatible products.
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Event Description
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It was reported that there was a thermal event.
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Search Alerts/Recalls
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