VOCSN
Report
- Report Number
- 3013095415-2025-01019
- Event Type
- Malfunction
- Date Received
- November 21, 2025
- Date of Event
- July 25, 2025
- Report Date
- November 21, 2025
- Manufacturer
- VENTEC LIFE SYSTEMS, INC
- Product Code
- CBK
- UDI-DI
- 00855573007747
- PMA / PMN Number
- K162877
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- 003
Narratives
H6: UPON RECEIPT OF THE DEVICE VENTEC DOWNLOADED ITS ELECTRONIC RECORDS (SYSTEM LOGS) FOR ANALYSIS AND OBSERVED THE DEVICE HAD PREVIOUSLY LOGGED MULTIPLE ABNORMAL POWER-ON EVENTS INDICATIVE OF A DEVICE REBOOT. VENTEC THEN OPENED THE DEVICE IN ORDER TO PERFORM A VISUAL INSPECTION AND OBSERVED THAT THE INTERNAL FLOW TRANSDUCER (IFT) CABLE WAS NOT FULLY SEATED TO THE IFT. VENTEC PLUGGED IN THE IFT CABLE INTO THE IFT TO RESOLVE THE REPORTED ISSUE. PROPER DEVICE OPERATION WAS THEN CONFIRMED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THE REPORTED ISSUE TO BE THAT THE IFT CABLE WAS NOT FULLY SEATED TO THE IFT.
IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON RECEIPT OF THE DEVICE, VENTEC DOWNLOADED ITS ELECTRONIC RECORDS (SYSTEM LOGS) FOR ANALYSIS AND OBSERVED THAT THE DEVICE HAD PREVIOUSLY LOGGED MULTIPLE REBOOT EVENTS. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT; HOWEVER, THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2462778 | VOCSN | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | VENTEC LIFE SYSTEMS, INC | V+O+C+S+N, ENGLISH | 00855573007747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |