Model Number 0010-0210R |
Device Problems
Smoking (1585); Defective Device (2588); Device Displays Incorrect Message (2591)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/20/2024 |
Event Type
malfunction
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Event Description
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It was reported that during a procedure, the console displayed error 211 and 213.The console was restarted, however, error 521 then displayed and a smell of smoke was reported.The biotech engineer attempted to restart the console to troubleshoot however, the console system did not work properly.The procedure was completed with the same device and no patient complications.
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Manufacturer Narrative
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The console was not returned for analysis; however, the console was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, the complaint could be confirmed.The power board fuses were measured, and it was found that the fuse for laser power was blown.Unit needs new power distribution board, so a new power distribution board was fitted.Also, it was attempted to turn on unit and the fan ruined but no power with key turn.Suspect problem to be transformer or pca board.The reason for burning smell, could not be determined due to a lack of a returned product and insufficient information to determine the most probable cause for the reported issue.Based on review of all information available and analysis results, a conclusion code of cause not established was assigned to this investigation.
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Event Description
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It was reported that during a procedure, the console displayed error 211 and 213.The console was restarted, however, error 521 then displayed and a smell of smoke was reported.The biotech engineer attempted to restart the console to troubleshoot however, the console system did not work properly.The procedure was completed with the same device and no patient complications.
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Search Alerts/Recalls
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