VITAL SIGNS¿
Received Sep 14, 2021 · Event occurred May 29, 2021
Report 12466664 · MDR key 12466664
Device
Generic name
Ventilator, Emergency, Manual (resuscitator)
Model number
A4UX2044Catalog number
A4UX2044
Lot number
21BJA124EXPO2/23
Product problems
- Material Puncture/Hole
- Defective Device
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
GASES PRESSURE BAG ON VITAL SIGNS ADULT ANESTHESIA BREATHING CIRCUIT HAS A SMALL HOLE IN THE SEAM AT THE END OF THE BAG. STAFF HAS REPORTED TO ME THERE WERE OTHERS THAT HAD THE SAME DEFECT HOWEVER, NONE WERE SAVED WITH CONCURRENT ITEM BAGS TO ATTAIN LOT NUMBERS. THE ONE I AM IN POSSESSION OF CURRENTLY DOESN'T HAVE THE ORIGINAL PACKAGING AS WELL OR A LOT NUMBER ON THE DEFECTIVE ITEM. MANUFACTURER RESPONSE FOR GASES PRESSURE BAG FOR VITAL SIGNS ADULT ANESTHESIA BREATHING CIRCUIT, (BRAND NOT PROVIDED) (PER SITE REPORTER). VENDOR REQUESTED WE SEND IN THE PACKAGING THE NEXT TIME IT OCCURS, REPLACEMENT PRODUCT RECEIVED.