Model Number 1688010000 |
Device Problems
Overheating of Device (1437); Temperature Problem (3022)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/14/2023 |
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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Alleged failure: per rep, the screen says overheating every 5 cases.Sprayed an air vent.Still overheating.The failure(s) identified in the investigation is consistent with the complaint record.Root cause: defective electrical component failure (altera chip) on the digital board.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
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Search Alerts/Recalls
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