FDA Adverse Event
Malfunction
Summary report: N
VOCSN
MDR report key: 11825528
·
Received May 14, 2021
Report
- Report Number
- 3013095415-2021-00022
- Event Type
- Malfunction
- Date Received
- May 14, 2021
- Date of Event
- April 14, 2021
- Report Date
- April 14, 2021
- Manufacturer
- VENTEC LIFE SYSTEMS, INC
- Product Code
- CBK
- PMA / PMN Number
- K162877
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
H6: VENTEC PERFORMED AN EVALUATION ON THE DEVICE AND WAS UNABLE TO CONFIRM OR REPRODUCE THE REPORTED ISSUE. THE INTERNAL FLOW TRANSDUCER, EXHALATION CONTROL MODULE AND CONTROL BOARD WERE REPLACED AS A PRECAUTION. 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
THE DEVICE HAS BEEN RETURNED TO VENTEC TO PERFORM AN 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 |
|---|---|---|---|---|---|---|---|
| 725906 | VOCSN | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | VENTEC LIFE SYSTEMS, INC | PRT-00490-001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |