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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNMED HOLDINGS, LLC OHMEDA MALE STEM Y FLOW METER CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

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SUNMED HOLDINGS, LLC OHMEDA MALE STEM Y FLOW METER CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Catalog Number 792-8-1321-01
Device Problem Break (1069)
Patient Problem Respiratory Distress (2045)
Event Date 12/28/2018
Event Type  Injury  
Event Description
Pin was broken off the male adapter of the regulator allowing it to be inserted in to the nitrous oxide outlet. Nitrous oxide was administered instead of oxygen causing the patient to go into respiratory distress. Patient was placed on a ventilator and admitted to the pediatric intensive care unit. (b)(4). Triage unit sequence # (b)(4).
 
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Brand NameOHMEDA MALE STEM Y FLOW METER
Type of DeviceCIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Manufacturer (Section D)
SUNMED HOLDINGS, LLC
MDR Report Key8358857
MDR Text Key137235682
Report NumberMW5084162
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/19/2019 Patient Sequence Number: 1
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