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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRI-ANIM OHMEDA Y FLOW METER

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TRI-ANIM OHMEDA Y FLOW METER Back to Search Results
Model Number MALE STEM
Device Problem Component Missing (2306)
Patient Problem Low Oxygen Saturation (2477)
Event Date 12/14/2018
Event Type  Injury  
Event Description
Pin was missing from the male adapter of the regulator allowing it to be inserted into the nitrous oxide outlet. Nitrous oxide was administered instead of supplemental oxygen during an mri procedure. Patient's oxygen saturation levels decreased during the inadvertent exposure and the mri was aborted. Patient returned to baseline once the medical gas was removed.
 
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Brand NameOHMEDA
Type of DeviceY FLOW METER
Manufacturer (Section D)
TRI-ANIM
MDR Report Key8413617
MDR Text Key138638593
Report Number8413617
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMALE STEM
Device Catalogue Number792-8-1321-01
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/01/2019
Distributor Facility Aware Date12/28/2018
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 03/04/2019 Patient Sequence Number: 1
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