BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOCSN

    MDR report key: 15525512 · Received October 1, 2022

    Report

    Report Number
    3013095415-2022-00789
    Event Type
    Malfunction
    Date Received
    October 1, 2022
    Date of Event
    June 14, 2022
    Report Date
    September 9, 2022
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED BY VENTEC WHERE THE REPORTED ISSUE OF THE DEVICE ALARMING DUE TO VERY LOW FIO2 (FRACTION OF INSPIRED OXYGEN) READINGS WAS CONFIRMED. VENTEC OBSERVED THAT THE OA2 CABLE WIRE HARNESS TO THE OAX BOARD HAD A BAD CRIMP TERMINAL CAUSING THE PIN IN THE JACK TO BE SHOVED BACK. THIS CREATED A TEMPORARY CONNECTION WHERE THE TIP OF THE PIN WAS RUBBING AGAINST THE BLUNT END OF THE TERMINAL IN THE OA2 CABLE WIRE HARNESS. AS A RESULT, ANY VIBRATION COULD BREAK THIS CONNECTION RENDERING THE O2 SENSOR USELESS AND REPORTING INCORRECT FIO2 LEVELS. VENTEC REPLACED THE OA2 CABLE WIRE HARNESS AND OAX BOARD TO RESOLVE THE REPORTED ISSUE. PROPER DEVICE OPERATION WAS THEN OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THE REPORTED ISSUE THAT THE OA2 CABLE WIRE HARNESS TO THE OAX BOARD HAD A BAD CRIMP TERMINAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT THE VENTILATOR PROVIDED AN ALARM INDICATING VERY LOW FIO2 (FRACTION OF INSPIRED OXYGEN) READINGS. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2647228 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC PRT-00900-001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown