FDA Adverse Event
Malfunction
Summary report: N
CIRCUIT COAX (A) 2.4M, B.EXT, 2L BAG GSE
MDR report key: 15263317
·
Received August 20, 2022
Report
- Report Number
- 3010838917-2022-00006
- Event Type
- Malfunction
- Date Received
- August 20, 2022
- Date of Event
- July 22, 2022
- Report Date
- July 22, 2022
- Manufacturer
- VYAIRE MEDICAL OY
- Product Code
- CAI
- UDI-DI
- 10190752136908
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
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 · 0
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE CIRCUIT COAX (A) 2.4M, B.EXT, 2L BAG GSE EXPERIENCED LEAKS GREATER THAN 750 MLS. THE INCIDENT OCCURRED DURING TESTING IN BETWEEN PATIENTS. THE OCCURRENCE CAUSED SIGNIFICANT DELAYS IN THE OPERATING LISTS. THERE WERE NO REPORTS OF INJURY/HARM TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2494399 | CIRCUIT COAX (A) 2.4M, B.EXT, 2L BAG GSE | CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) | CAI | VYAIRE MEDICAL OY | CIRCUIT COAX (A) 2.4M, B.EXT, 2L BAG GSE | 10190752136908 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |