MalfunctionBTM
VITAL SIGNS¿
Received Nov 25, 2024 · Event occurred Oct 29, 2024
Report 20770976 · MDR key 20770976
Device
Generic name
Ventilator, Emergency, Manual (resuscitator)
Manufacturer
Vyaire Medical, Inc.Model number
A4FX2004Catalog number
A4FX2004
Lot number
0004289252
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE IS CONDENSATION VISIBLE INSIDE THE BLUE PLASTIC FILTER CONTAINING PIECE OF A SINGLE USE ADULT ANESTHESIA BREATHING CIRCUIT. THE PACKAGE WAS NOT YET OPEN BUT YOU CAN SEE WATER DROPLETS/CONDENSATION ON THE BLUE PIECE INSIDE OF THE BAG THAT THE CIRCUIT CAME IN.