BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOCSN

    MDR report key: 12009595 · Received June 16, 2021

    Report

    Report Number
    3013095415-2021-00030
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    March 26, 2021
    Report Date
    May 17, 2021
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR AN INVESTIGATION. THE INVESTIGATION DETERMINED THAT THERE WAS AN ELECTRICAL SHORT DUE TO EXPOSED SHIELDING ON THE LCD CABLE, WHICH CAUSED THE ISSUE. AFTER REPAIR, PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FOR OTHER UNRELATED REPAIRS. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED A FAILURE THAT CAUSED THE DEVICE TO UNEXPECTEDLY SHUT DOWN WHILE IN USE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910480 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC PRT-00490-001

    Patients

    Seq Age Sex Outcome Treatment
    1