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Model Number 744000 |
Device Problem
Output below Specifications (3004)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The unit was inspected, tested.During testing it was found the output power of des 120w was low due to faulty psu (power supply unit) board.After using the reference psu test board, the unit passed the functional tests.The current software is v3.03.In addition, during inspection it was found the unit missing 2 mounting feet.The housing has multiple minor scratches.Review of fault log shows 400 ref 26, nine times, this is generated if a turis electrode is attached and activated without a saline solution being present, or there is an electrode connection fault.Investigation is ongoing.This report will be supplemented accordingly following investigation.
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Event Description
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As reported , during an asset return inspection, the unit was found with low power output (des 120w) due to faulty psu (power supply unit) board.There is no patient involvement associated on this reported event.No user injury reported.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 9 years since the subject device was manufactured.Based on the results of the investigation, the specific root cause of the power supply unit board could not be determined at this time.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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