InjuryBTM
AIRFLOW TM SMALL ADULT RESPIRATOR WITH MANOMETER, FILTER, MASK, AND BAG RESERVOI
Received Feb 28, 2022
Report MW5107784 · MDR key 13634498
Device
Generic name
Ventilator, Emergency, Manual (resuscitator)
Manufacturer
Sunmed Holdings, Llc.Catalog number
AF5140MBP
Lot number
2109292
Product problems
- Improper Flow or Infusion
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
THERE APPEARS TO BE RETROGRADE FLOW VIA A FAULTY VALVE IN THE MANOMETER ALLOWING FOR REBREATHING OF CO2. FDA SAFETY REPORT ID# (B)(4).