Model Number 0475100000 |
Device Problems
Sparking (2595); Temperature Problem (3022)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/09/2022 |
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 was not during a procedure.
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Event Description
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It was reported that there was a thermal event.Please note this was not during a procedure.
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Manufacturer Narrative
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This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: sparked.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 reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.
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Search Alerts/Recalls
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