BEUDAMED
    FDA Adverse Event Death Summary report: N

    VOCSN

    MDR report key: 12380071 · Received August 27, 2021

    Report

    Report Number
    3013095415-2021-00218
    Event Type
    Death
    Date Received
    August 27, 2021
    Date of Event
    July 14, 2021
    Report Date
    July 29, 2021
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO VENTEC FOR AN EVALUATION. VENTEC PERFORMED AN EVALUATION ON THE DEVICE AND DOWNLOADED THE DEVICE'S ELECTRONIC LOGS. VENTEC CONFIRMED THAT THE DEVICE WAS OPERATING TO SPECIFICATION AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. 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. VENTEC REVIEWED THE PRESET (#2) THAT WAS USED BY THE CUSTOMER AT THE TIME OF THE EVENT AND OBSERVED THAT THE PATIENT CIRCUIT DISCONNECT ALARM WAS TURNED OFF. AS THIS ALARM WAS TURNED OFF, THE DEVICE WOULD NOT ALARM FOR ALARMS THAT ARE TURNED OFF AND THE DEVICE WAS OPERATING AS INTENDED.

    Description of Event or Problem · 1

    A DIRECTOR OF RESPIRATORY REPORTED TO VENTEC THAT A PATIENT EXPIRED WHILE ON THE VENTILATOR. THE FACILITY STATED THAT THERE WAS NO AUDIBLE ALARM WHEN THE PATIENT WAS DISCONNECTED FROM THE VENTILATOR. THE CUSTOMER WAS NOT SURE IF THE PATIENT EXPIRED AS A RESULT OF BEING DISCONNECTED OR IF HE WAS DISCONNECTED AT ALL. THE CUSTOMER ALSO STATED THAT THEY BELIEVE HE EXPIRED DUE TO CARDIAC ARREST. THERE ARE NO ALLEGATIONS OF A DEVICE MALFUNCTION, THE CUSTOMER WAS REQUESTING THE LOGS FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275661 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC PRT-00490-001

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death