Model Number UHI-4 |
Device Problem
Calibration Problem (2890)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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The device referenced in this report has been evaluated by olympus.The definitive cause of the customer's experience cannot be determined at this time.The investigation is ongoing.Physical evaluation of the complaint device reveals: the user's report is confirmed.The reading is not accurate to the flow due to the device being out of calibration.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
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Event Description
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It is reported during maintenance of a high flow insufflation device, the pressure reading was not accurate to the flow.There was no patient contact/impact related to this occurrence.
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Manufacturer Narrative
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There is more information for the device.This supplemental report is being submitted to provide this information.The device history record review confirmed that device has no abnormalities, special adoption, or variations in manufacturing.
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Search Alerts/Recalls
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