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

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).

• Brand Name: OHMEDA MALE STEM Y FLOW METER
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): SUNMED HOLDINGS, LLC
• MDR Report Key: 8358857
• MDR Text Key: 137235682
• Report Number: MW5084162
• 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: 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 Received: 02/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 792-8-1321-01
• Is the Reporter a Health Professional?: Yes
• 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: 05 YR