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

Model Number MALE-STEM

Device Problems Improper or Incorrect Procedure or Method (2017); Component Missing (2306)

Patient Problem Low Oxygen Saturation (2477)

Event Date 12/28/2018

Event Type  Injury  

Event Description

Pin was missing from the male adapter of the regulator allow ing it to be inserted into the nitrous oxide outlet.Pt o2 saturation levels decreased during the inadvertent exposure and the mri was aborted.Pt returned to baseline once the medical gas was removed.

• Brand Name: OHMEDA
• Type of Device: Y-FLOW METER
• Manufacturer (Section D): TRI-ANIM
• MDR Report Key: 8413614
• MDR Text Key: 138705412
• Report Number: 8413614
• Device Sequence Number: 1
• Product Code: BSZ
• 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
• Distributor Facility Aware Date: 12/28/2019
• 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): Required Intervention
• Patient Age: 60 YR