VITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUIT
Received Nov 8, 2021 · Event occurred May 29, 2021
Report 8030673-2021-00215 · MDR key 12776024
Device
Generic name
Ventilator, Emergency, Manual (resuscitator)
Manufacturer
Vyaire MedicalModel number
ITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUITCatalog number
A4UX2044
Lot number
NOT PROVIDED
Product problems
- Material Puncture/Hole
- Material Puncture/Hole
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
(B)(4). AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
THE CUSTOMER FILE THE REGULATORY REPORT UNDER UF REPORT# (B)(4). REPORTING AN ISSUE ON A4UX2044 VITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUIT WITH A SMALL HOLE IN THE SEAM AT THE END OF THE BAG. THERE IS NO INFORMATION ON PATIENT INVOLVEMENT, HOWEVER, THE ISSUE OCCURRED IN THE OPERATING ROOM.