FDA Adverse Event
Injury
Summary report: N
FLEXIBLE PATIENT CIRCUIT, 3100A 380-88/400-00 IN HEATED ENVIRONMENT (BOX OF 4)
MDR report key: 16364719
·
Received February 13, 2023
Report
- Report Number
- 8030673-2023-00300
- Event Type
- Injury
- Date Received
- February 13, 2023
- Date of Event
- January 16, 2023
- Report Date
- February 13, 2023
- Manufacturer
- VYAIRE MEDICAL INC.
- Product Code
- LSZ
- UDI-DI
- 50190752155464
- PMA / PMN Number
- P890057
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- 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. NO ROOT CAUSE HAS BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE NOT RETURNED YET.
Description of Event or Problem · 0
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 771465 - CKT W/SHRT HTD WIRE 380-88 &400 BX4 WAS BECOMING DISCONNECTED WHILE ON THE PATIENT. THEY USED TAPE TO SECURE THE CIRCUIT. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 721209 | FLEXIBLE PATIENT CIRCUIT, 3100A 380-88/400-00 IN HEATED ENVIRONMENT (BOX OF 4) | VENTILATOR, HIGH FREQUENCY | LSZ | VYAIRE MEDICAL INC. | CKT W/SHRT HTD WIRE 380-88 &400 BX4 | 0004190692 | 50190752155464 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |