VITAL SIGNS¿ ADULT ANESTHESIA BREATHING CIRCUIT
Received Mar 29, 2023 · Event occurred Mar 10, 2023
Report 8030673-2023-00308 · MDR key 16639545
Device
Generic name
Ventilator, Emergency, Manual (resuscitator)
Manufacturer
Vyaire Medical Inc.Model number
ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAGCatalog number
ADU320X4D
Lot number
0004237265
Product problems
- Deflation Problem
- Deflation Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER DID NOT SEND PHYSICAL SAMPLE AND PICTURES SINCE THE SAMPLE USED DUE TO SUPPLY NEEDS. THEREFORE, NO ROOT CAUSE COULD BE DETERMINED. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE USED DUE TO SUPPLY NEEDS.
Description of Event or Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT MANY OF THEIR ADU320X4D ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG HAVE BEEN COMING IN WITHOUT ANY AIR IN THE MASK OR WITH VERY LITTLE AIR. THEY ARE ALL DEFLATED. THIS CAN CAUSE PROBLEMS IN THE CASE OF EMERGENCIES. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM/INJURY ASSOCIATED WITH THE EVENT.