BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SSCOR INC

    MDR report key: 16967314 · Received May 19, 2023

    Report

    Report Number
    2022724-2023-00001
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    April 7, 2023
    Report Date
    May 18, 2023
    Manufacturer
    SSCOR INC
    Product Code
    BTA
    UDI-DI
    B2452310BV0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SSCOR REACHED OUT TO INITIAL REPORTED TO OBTAIN ADDITIONAL INFORMATION. INITIAL REPORTED STATED THAT DURING A CARDIAC ARREST CALL THE PARAMEDIC CALLED HIM TO HELP TROUBLESHOOT A DEVICE THAT WAS FAILING SUCTION AND SHUTTING OFF WITH IN TWO MINUTES, BUT WAS UNABLE TO HELP TROUBLE SHOOT AS DEVICE KEPT SHUTTING OFF. WHEN THE AMBULANCE CAME BACK THE DEVICE WAS PLACED ON THE CRADLE AND CHARGED FOR 5-6 HOURS. DEVICE WAS TURNED ON AND MIMICKED SUCTION BUT DEVICE SHUT OFF WITHIN 40 SECONDS. OTHER DEVICES WERE CHECKED AND THOSE HAD NO ISSUES. PER INITIAL REPORTED BATTERY MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO OUTCOME OF PATIENT. DEVICE WAS RETURNED FOR EVALUATION. SSCOR TESTED DEVICE TO SSCOR SPECIFICATIONS AND CONFIRMED THAT DEVICE MALFUNCTION WAS TO LOW BATTERY CAPACITY. SSCOR HAS ADVISED CUSTOMER TO PERFORM BATTERY TESTS AS STATED IN PRODUCT MANUAL AND HAS ISSUED A REPLACEMENT DEVICE.

    Description of Event or Problem · 0

    DURING A CARDIAC ARREST CALL DEVICE TURNED ON BUT DIED WITH IN 20 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075835 SSCOR INC SSCOR VX-2 BTA SSCOR INC 2310BV N/A B2452310BV0

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown