FDA Adverse Event
Malfunction
Summary report: N
AVEA VENTILATOR
MDR report key: 8035088
·
Received November 2, 2018
Report
- Report Number
- 2021710-2018-09478
- Event Type
- Malfunction
- Date Received
- November 2, 2018
- Date of Event
- October 3, 2018
- Report Date
- October 3, 2018
- Manufacturer
- VYAIRE MEDICAL
- Product Code
- CBK
- PMA / PMN Number
- K103211
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AT THIS TIME, VYAIRE HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FOR EVALUATION.
Additional Manufacturer Narrative · 1
THE VYAIRE FAILURE ANALYSIS LABORATORY RECEIVED THE SUSPECT COMPONENT AND PERFORMED A FAILURE INVESTIGATION. THE REPORTED ISSUE WAS DUPLICATED IN THE LABORATORY SETTING. BENCH TESTING REVEALED THE U29 COMPONENT WAS DEFECTIVE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED WHILE USING THE AVEA VENTILATOR, THE USER INTERFACE MODULE (UIM) TOUCHSCREEN IS NOT WORKING ON START UP. THE CUSTOMER STATED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 874803 | AVEA VENTILATOR | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | VYAIRE MEDICAL | AVEA COMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |