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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HIGH FLOW INSUFFLATION UNIT
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OLYMPUS MEDICAL SYSTEMS CORP. HIGH FLOW INSUFFLATION UNIT Back to Search Results
Model Number UHI-4
Device Problem Calibration Problem (2890)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
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.
 
Manufacturer Narrative
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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Brand Name
HIGH FLOW INSUFFLATION UNIT
Type of Device
HIGH FLOW INSUFFLATION UNIT
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key11293990
MDR Text Key231441609
Report Number8010047-2021-02377
Device Sequence Number1
Product Code HIF
UDI-Device Identifier04953170324147
UDI-Public4953170324147
Combination Product (y/n)N
PMA/PMN Number
K122180
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 03/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUHI-4
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2021
Was the Report Sent to FDA? No
Date Manufacturer Received02/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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