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