BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SSCOR INC

    MDR report key: 17322039 · Received July 13, 2023

    Report

    Report Number
    2022724-2023-00003
    Event Type
    Malfunction
    Date Received
    July 13, 2023
    Date of Event
    May 11, 2023
    Report Date
    July 13, 2023
    Manufacturer
    SSCOR INC.
    Product Code
    JCX
    UDI-DI
    B2452310BV0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 RECEIVED A CALL FOR A PATIENT THAT WAS ON CARDIAC ARREST, COUGHING BLOOD AND HAD A COMPROMISED AIRWAY. DEVICE DIED WITH IN TWO MINUTES INTO THE CALL, A SECOND ASPIRATOR WAS USED TO SUCTION. REPORTER STATED THAT ONCE THEY WERE BACK AT THE STATION THEY NOTICED THE BATTERY WAS HOT . THE BATTERY WAS INSPECTED AND IT WAS NOT WORN OR DAMAGED, THE BATTERY SEEMED NEW. ONCE THE BATTERY COOLED OFF DEVICE STARTED WORKING PROPERLY. PER INITIAL REPORTER BATTERY MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO OUTCOME OF PATIENT DEVICE WAS NOT RETURNED FOR EVALUATION. SSCOR HAS REQUESTED REPORTER TO RETURN NON-CONFORMING BATTERY FOR EVALUATION. ONCE BATTERY EVALUATION IS CONCLUDED AN ADDITIONAL REPORT WILL BE SUBMITTED. SSCOR HAS ISSUED A REPLACEMENT BATTERY AND ADVISED REPORTER TO PERFORM BATTERY TESTS AS STATED IN PRODUCT MANUAL.

    Description of Event or Problem · 0

    BATTERY FAILED DURING A CARDIAC ARREST CALL. DEVICE STOPPED WORKING WITH IN TWO MINUTES INTO THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196248 SSCOR INC S-SCORT III JCX SSCOR INC. 74000 N/A B2452310BV0

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown