Model Number OER-PRO |
Device Problem
Device Alarm System (1012)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/06/2020 |
Event Type
malfunction
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Manufacturer Narrative
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An olympus field service engineer (fse) was dispatched to service the device.The device passed all the service inspections.Software attributes have been verified and confirmed.No other issues were reported.If additional information is obtained a supplemental report will be filed.
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Event Description
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A user facility reported that while loading liquid chemical germicide (lcg), the endoscope reprocessor never stopped beeping.The customer stated that they tried the load again and the unit shut off too quickly.No patient involvement or injuries were reported.No additional information has been obtained.
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Manufacturer Narrative
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The investigation has been completed.A device history record (dhr) review was performed and found no non-conformances that would cause the reported malfunction.All records indicate that the device was manufactured in accordance with all applicable procedures.The instructions for use (ifu) states: ¿the max line and min line of the disinfectant solution indicator are the reference line that indicates too much disinfectant solution or insufficient amount of disinfectant solution in the tank.¿.The root cause could not be conclusively determined.Probable causes that could have led to the reported event include that since the beep turned off when the user retried loading, the amount of the loaded solution was seemingly insufficient in the basin.It may have caused the suggested event.
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Search Alerts/Recalls
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