BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SSCOR, INC.

    MDR report key: 24309064 · Received February 10, 2026

    Report

    Report Number
    2022724-2026-00001
    Event Type
    Malfunction
    Date Received
    February 10, 2026
    Report Date
    February 10, 2026
    Manufacturer
    SSCOR, INC
    Product Code
    BTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SSCOR HAS ADVISED REPORTER TO FOLLOW PROPER BATTERY MAINTENANCE PER APPROVED MANUAL AND TO REPLACE BATTERIES EVERY 3 YEARS. AS A COURTESY SSCOR HAS ISSUED A REPLACEMENT BATTERY.

    Description of Event or Problem · 0

    REPORTER STATED THAT DEVICE FAILED WHILE ON A CODE. THE UNIT WORKED WHILE ON THE CRADDLE, BUT IT WOULD TURN OFF ONCE TAKEN OFF. REPORTED HAS MENTIONED THAT BATTERY ON DEVICE HAS NEVER BEEN REPLACED SINCE DEVICE WAS PURCHASED. THERE WAS AN ALTERNATE DEVICE THAT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368891 SSCOR, INC. SSCORT 2100S BTA SSCOR, INC 2100S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown