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

Model Number MALE-STEM

Device Problems Gas Output Problem (1266); Misconnection (1399); Component Missing (2306)

Patient Problem Respiratory Distress (2045)

Event Date 11/29/2018

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.Pt experienced respiratory distress and was provided breathing support to maintain oxygenation levels.The pt was admitted to the pediatric intensive care unit for further monitoring.

• Brand Name: OHMEDA
• Type of Device: Y-FLOW ANIM
• Manufacturer (Section D): TRI-ANIM
• MDR Report Key: 8413564
• MDR Text Key: 138586782
• Report Number: 8413564
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 03/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: MALE-STEM
• Device Catalogue Number: 792-8-1321-01
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 8 YR
• Patient Weight: 7