FDA Adverse Event
Malfunction
Summary report: N
VOCSN
MDR report key: 11703908
·
Received April 21, 2021
Report
- Report Number
- 3013095415-2021-00016
- Event Type
- Malfunction
- Date Received
- April 21, 2021
- Date of Event
- October 15, 2020
- Report Date
- March 22, 2021
- Manufacturer
- VENTEC LIFE SYSTEMS, INC
- Product Code
- CBK
- PMA / PMN Number
- K162877
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
H6. VENTEC PERFORMED AN INVESTIGATION ON THE RETURNED DEVICE.THE REPORTED EVENT OF UNEXPECTED SHUTDOWN WAS CONFIRMED. IT APPEARS THAT THE DEVICE HAS BEEN DROPPED. VENTEC REPLACED THE MOTHERBOARD PRINTED CIRCUIT BOARD (PCB) AS A PRECAUTION. AFTER REPLACING THE PCB, PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE CAUSE FOR THE REPORTED ISSUE COULD NOT BE CONCLUSIVELY DETERMINED.
Additional Manufacturer Narrative · 1
VENTEC PERFORMED AN INITIAL EVALUATION ON THE DEVICE BUT A CONCLUSION IS NOT YET AVAILABLE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE AS DEFINED BY 21 CFR 803.56.
Description of Event or Problem · 1
IT WAS REPORTED THAT A DEVICE UNEXPECTEDLY SHUT DOWN WHILE A PATIENT WAS UNDER TREATMENT. THERE WAS NO PATIENT HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 596771 | VOCSN | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | VENTEC LIFE SYSTEMS, INC | PRT-01100-000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |