BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SSCOR, INC

    MDR report key: 21684453 · Received March 24, 2025

    Report

    Report Number
    2022724-2025-00001
    Event Type
    Malfunction
    Date Received
    March 24, 2025
    Date of Event
    February 23, 2025
    Report Date
    March 24, 2025
    Manufacturer
    SSCOR INC.
    Product Code
    BTA
    UDI-DI
    B2452310BV0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2025 (B)(6) FIRE DEPT. REPORTED THAT DEVICE SN (B)(6) DIED AT THE END OF AN CARDIAC ARREST CALL. DEVICE DIED WITH IN 30 MINUTES INTO THE CALL AS FAR AS TO WHEN VOLUNTEER WENT TO DO INTUBATION. REPORTED STATED THAT DEVICE IS ALWAYS KEPT ON CHARGE. SSCOR ISSUED A REPLACEMENT BATTERY TO RESOLVE THEIR ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2099328 SSCOR, INC SSCOR VX-2 BTA SSCOR INC. 2310BV B2452310BV0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown