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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 Electrical /Electronic Property Problem (1198)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to olympus for evaluation.During the evaluation, the user¿s report was confirmed due to a faulty control printed circuit board (pcb) of the front panel.No other issues were found during the device inspection.If additional information is provided a supplemental report will be filed.
 
Event Description
A user facility reported that the cavity mode was not working properly and the led lights were both lit.No patient involvement or injuries were reported.No additional information has been obtained.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer¿s final investigation.The device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device.The device met all specifications at the time of shipment.Based on the legal manufacturer's investigation, the failure of the control board of the front panel was likely due to aging, since the device was manufactured over 5 years ago (january 2015).
 
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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 Key10868220
MDR Text Key217188682
Report Number8010047-2020-09159
Device Sequence Number1
Product Code HIF
Combination Product (y/n)N
PMA/PMN Number
K122180
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 01/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2020
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 Manufacturer10/28/2020
Was the Report Sent to FDA? No
Date Manufacturer Received01/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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