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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-2
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Heart Failure (2206)
Event Date 08/09/2018
Event Type  Injury  
Manufacturer Narrative
The subject device referenced in this report has not yet been returned to olympus for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.If additional information or the subject device is received at a later time, this report will be supplemented.
 
Event Description
During a laparoscopy, the subject device was used.The patient suffered from heart failure and the doctor managed to revive the patient.The malfunction of the subject device has not been reported.
 
Manufacturer Narrative
This is a supplemental report to provide additional information.Omsc obtained additional information as follows; the using facility considered that the use of the subject device was not the cause for the heart failure.Therefore omsc retracts this mdr.
 
Manufacturer Narrative
This supplemental report is submitting to correct "device product code".
 
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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
MDR Report Key7836491
MDR Text Key118868578
Report Number8010047-2018-01678
Device Sequence Number1
Product Code HIF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup,Followup
Report Date 03/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberUHI-2
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/10/2018
Initial Date FDA Received08/31/2018
Supplement Dates Manufacturer Received10/16/2018
02/20/2019
Supplement Dates FDA Received10/18/2018
03/13/2019
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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