BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SSCOR INC

    MDR report key: 19337715 · Received May 16, 2024

    Report

    Report Number
    2022724-2024-00004
    Event Type
    Malfunction
    Date Received
    May 16, 2024
    Date of Event
    April 3, 2024
    Report Date
    May 16, 2024
    Manufacturer
    SSCOR INC.
    Product Code
    BTA
    UDI-DI
    B2452310BV0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER CLAIM COULD NOT BE CONFIRMED AS DEVICE WAS NOT RETURNED FOR EVALUATION. SSCOR REACHED OUT TO REPORTED TO RECEIVE ADDITIONAL INFORMATION. REPORTED STATED THAT THEY WERE INTO A CARDIAC ARREST CALL AND DEVICE DIED DURING THE EMERGENCY CALL. REPORTED STATES THAT DEVICES WERE NOT BEING SERVICED AS OFTEN AS THEY SHOULD. SSCOR HAS ISSUED REPLACEMENT BATTERY AND HAS ADVISED REPORTED TO PERFORM BATTERY MAINTENANCE AS STATED ON DEVICE INSTRUCTION MANUAL. AFTER BATTERY WAS SHIPPED, SSCOR TECH SUPPORT REACHED OUT TO REPORTER AND REPORTER STATED THAT REPLACING THE BATTERY HAS RESOLVED THEIR ISSUE.

    Description of Event or Problem · 0

    BATTERY FAILURE, UNIT DID NOT HOLD A CHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2500179 SSCOR INC SSCOR VX-2 BTA SSCOR INC. 2310BV B2452310BV0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown