FDA Adverse Event
Malfunction
Summary report: N
VELA VENTILATOR
MDR report key: 18895022
·
Received March 13, 2024
Report
- Report Number
- 2021710-2024-18883
- Event Type
- Malfunction
- Date Received
- March 13, 2024
- Date of Event
- February 15, 2024
- Report Date
- March 13, 2024
- Manufacturer
- VYAIRE MEDICAL
- Product Code
- CBK
- UDI-DI
- 10846446001419
- PMA / PMN Number
- K093094
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). H3: 81 OTHER - THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE UNIT WAS NOT RETURNED; THEREFORE A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, THE CUSTOMER PLACED AN ORDER FOR MAIN BOARD REPLACEMENT AND PART WILL BE SHIPPED. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. H3 OTHER TEXT : DEVICE NOT RETURNED.
Description of Event or Problem · 0
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR AD AN XDCR FAULT, MOTOR FAULT, HW FAULT, POST DAC AND ADC ERROR DURING EXTENDED SYSTEMS TEST (EST)/USER VERIFICATION TESTS (UVT). FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 184671 | VELA VENTILATOR | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | VYAIRE MEDICAL | VELA | 10846446001419 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |