Model Number 0475100000 |
Device Problems
Thermal Decomposition of Device (1071); Electrical Power Problem (2925)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/04/2022 |
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.
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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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The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence. alleged failure: electrical issue.Confirmed failure: software upgrade, not related to 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.The failure mode will be monitored for future reoccurrence. manufacture date is not known.
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Search Alerts/Recalls
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