BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SSCOR INC

    MDR report key: 15565814 · Received October 7, 2022

    Report

    Report Number
    2022724-2022-00001
    Event Type
    Malfunction
    Date Received
    October 7, 2022
    Date of Event
    July 24, 2022
    Report Date
    August 24, 2022
    Manufacturer
    SSCOR INC
    Product Code
    BTA
    PMA / PMN Number
    K945929
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SSCOR REACHED OUT TO INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION. INITIAL REPORTER STATED THAT THEY WERE ON A CALL AND DEVICE CEASED RUNNING WITHIN TWO MINUTES. THEY HAD TO USE A SECONDARY SUCTION DEVICE FOR 1 OR 2 MINUTES UNTIL PATIENT WAS ON TRANSPORT. PATIENT HAD NO PULSE ON ARRIVAL AND COULD NOT BE RESUSCITATED. INITIAL REPORTER STATED THAT THE DEVICE DID NOT CONTRIBUTE TO PATIENT OUTCOME. AFTER THE CALL DEVICE WAS PLACED ON CHARGE BRACKET FOR 1 HR AND THEN IT WAS TAKEN OFF AND THE DEVICE DIED WITH IN 2 MINUTES. ONCE THEY ARRIVED TO THE STATION DEVICE WAS PLUGGED INTO THE WALL CHARGER FOR 6-7 HOURS AND THEN AGAIN IT DIED WITH IN 2 MINUTES AND THAT IS WHEN THE INITIAL REPORTER REALIZED THE BATTERY HAD LOST CAPACITY.

    Description of Event or Problem · 0

    MEDIC UNIT STARTED TO SUCTION AIRWAY AND BATTERY DIED WITHIN TWO MINUTES OF SUCTIONING. THEY HAD TO MOVE PATIENT TO THE MEDIC UNIT TO USE ON BOARD SUCTION TO COMPLETE EVACUATION OF EMESIS AND FLUID IN AIRWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274957 SSCOR INC SSCOR VX-2 BTA SSCOR INC 2310BV N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown