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Model Number UHI-4 |
Device Problems
False Alarm (1013); No Display/Image (1183); Display or Visual Feedback Problem (1184)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/17/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, as noted in event, the user¿s report was confirmed due to a faulty motherboard.If additional information becomes available following the device evaluation, a supplemental report will be filed.
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Event Description
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The customer reported that during preparation for use when he turned on his olympus high flow insufflation unit, the device alarm sounded.According to the initial reporter, this event occurred outside of the procedure and had no impact on the patient.During the device evaluation, it was discovered that the device¿s motherboard was defective, causing no image to appear and the device alarm to sound.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the approved final investigation.A correction to b5 and h6 is being made to clarify the potential adverse event.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the definitive root cause of the faulty circuit board could not be determined.Olympus will continue to monitor field performance for this device.
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Event Description
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The customer reported that during preparation for use when he turned on his olympus high flow insufflation unit, the device alarm sounded.According to the initial reporter, this event occurred outside of the procedure and had no impact on the patient.During the device evaluation, it was discovered that the device¿s motherboard was defective, causing the display to turn off and the device alarm to sound.This report was submitted for the malfunction found during evaluation.
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Search Alerts/Recalls
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