FDA Adverse Event
Death
Summary report: N
VOCSN PRO
MDR report key: 17808612
·
Received September 25, 2023
Report
- Report Number
- MW5146101
- Event Type
- Death
- Date Received
- September 25, 2023
- Report Date
- September 19, 2023
- Manufacturer
- VENTEC LIFE SYSTEMS, INC.
- Product Code
- CBK
- Report Source
- Voluntary report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PT WAS ON VENTILATOR AT TIME OF DEATH. OXIMETER WAS IN THE HOME BUT CAN'T VERIFY IF PT WAS USING AT TIME OF DEATH. DOWNLOAD WAS DONE ON VENTILATOR AFTER WE RECEIVED BACK FROM PT'S CAREGIVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1295117 | VOCSN PRO | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | VENTEC LIFE SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Death |