BEUDAMED
    FDA Adverse Event Death Summary report: N

    VOCSN

    MDR report key: 11529749 · Received March 19, 2021

    Report

    Report Number
    3013095415-2021-00005
    Event Type
    Death
    Date Received
    March 19, 2021
    Date of Event
    April 3, 2020
    Report Date
    March 19, 2021
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE THIRD PARTY SERVICE AGENT EVALUATED THE DEVICE AND DOWNLOADED THE DEVICE'S ELECTRONIC LOGS. THE THIRD PARTY SERVICE AGENT CONFIRMED THE DEVICE WAS OPERATING TO SPECIFICATION AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS NOT RETURNED TO VENTEC FOR AN EVALUATION. VENTEC REVIEWED THE ELECTRONIC LOGS AROUND THE REPORTED EVENT DATE AND TIME, WHICH INDICATED NOMINAL DEVICE OPERATION. THERE WERE NO ALARMS THAT WOULD INDICATE THERE WAS A MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VENTEC, "A RESIDENT PASSED AWAY ON THIS UNIT AT TULIP. THEY SAID THERE WAS NO MALFUNCTION WITH THE DEVICE. THEY JUST WANTED A COPY OF THE ALARM LOGS AND A 3RD PARTY EVAL DUE TO LEGAL REASONS. FACILITY REQUESTED A COPY OF THE ALARM LOGS DATED 4/3 AT APPROXIMATELY 1:00 PM FOR THEIR REVIEW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419859 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC PRT-00490-001

    Patients

    Seq Age Sex Outcome Treatment
    1 Death