Model Number 0475000100 |
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 11/23/2022 |
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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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: burning out of the box.Probable root cause: improper set-up conditions.Poor airflow in console.Poor ventilation around console.Ambient temperature around console higher than recommended".The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.
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Search Alerts/Recalls
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