MAUDE Adverse Event Report: SUNMED HOLDINGS, LLC. AIRFLOW TM SMALL ADULT RESPIRATOR WITH MANOMETER, FILTER, MASK, AND BAG RESERVOI; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Catalog Number AF5140MBP

Device Problem Improper Flow or Infusion (2954)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

There appears to be retrograde flow via a faulty valve in the manometer allowing for rebreathing of co2.Fda safety report id# (b)(4).

• Brand Name: AIRFLOW TM SMALL ADULT RESPIRATOR WITH MANOMETER, FILTER, MASK, AND BAG RESERVOI
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): SUNMED HOLDINGS, LLC.
• MDR Report Key: 13634498
• MDR Text Key: 286463439
• Report Number: MW5107784
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AF5140MBP
• Device Lot Number: 2109292
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening