FDA Adverse Event
Death
Summary report: N
AVEA VENTILATOR
MDR report key: 16448833
·
Received February 27, 2023
Report
- Report Number
- 2021710-2023-17345
- Event Type
- Death
- Date Received
- February 27, 2023
- Date of Event
- January 31, 2023
- Report Date
- February 27, 2023
- Manufacturer
- VYAIRE MEDICAL
- Product Code
- CBK
- UDI-DI
- 10846446000313
- PMA / PMN Number
- K103211
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE VENTILATION STOPPED AFTER CIRCUIT OCCLUSION ALARM OCCURRED AND A PATIENT DIED WHILE CONNECTED TO THE VENT. CORRECTION: A1:CORRECTED PATIENT IDENTIFIER . B1:CORRECTED REPORT TYPE. H1:CORRECTED TYPE OF REPORTABLE EVENT. H6:CORRECTED HEALTH IMPACT AND CLINICAL CODE.
Additional Manufacturer Narrative · 0
VYAIRE FILE IDENTIFICATION: (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 · 0
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR ALARMED CIRCUIT OCCLUSION. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 409324 | AVEA VENTILATOR | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | VYAIRE MEDICAL | AVEA VENTILATOR | 10846446000313 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Death |