Model Number 0475100000 |
Device Problems
Thermal Decomposition of Device (1071); Temperature Problem (3022)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/06/2022 |
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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Alleged failure: smoking and making audible popping noises.Confirmed failure: swu.Rcs.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.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.
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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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