BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SSCOR INC

    MDR report key: 16230242 · Received January 23, 2023

    Report

    Report Number
    2022724-2022-00002
    Event Type
    Malfunction
    Date Received
    January 23, 2023
    Date of Event
    November 24, 2022
    Report Date
    January 23, 2022
    Manufacturer
    SSCOR INC
    Product Code
    BTA
    UDI-DI
    B2452310BV0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 STATES THE UNIT WORKS TO SPECIFICATION. HOWEVER, WHEN RESPONDING TO A CARDIAC ARREST, THE DEVICE DID NOT RUN FROM BATTERY POWER. INITIAL REPORTER CHECKED WITH TEAM IF BATTERY WAS CHECKED AND DISCOVERED THAT IT WAS USER ERROR AS BATTERY WAS CHECKED WHILE DEVICE WAS ON BRACKET. BATTERY MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO OUTCOME OF PATIENT. BATTERY NOR DEVICE HAVE BEEN RETURNED FOR EVALUATION. SSCOR HAS ADVISED CUSTOMER TO PERFORM BATTERY TESTS AS STATED IN PRODUCT MANUAL AND HAS ISSUED REPLACEMENT BATTERY FOR DEVICE.

    Description of Event or Problem · 0

    MEDIC UNIT WAS RESPONDING TO A CALL FOR CARDIAC PROBLEM. DURING INTUBATION DEVICE WAS UNABLE TO SUCTION AND MEDIC UNIT HAD TO WAIT FOR A WORKING UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455230 SSCOR INC SSCOR VX-2 BTA SSCOR INC 2310BV N/A B2452310BV0

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention