BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SSCOR

    MDR report key: 11898738 · Received May 27, 2021

    Report

    Report Number
    2022724-2021-00001
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    April 24, 2021
    Report Date
    May 27, 2021
    Manufacturer
    SSCOR INC.
    Product Code
    JCX
    PMA / PMN Number
    K791210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSUFFICIENT INFORMATION WAS PROVIDED TO SSCOR INC. RELATING THE EVENT REPORTED. SSCOR ATTEMPTED TO OBTAIN ADDITIONAL PATIENT, EVENT AND DEVICE USAGE INFORMATION FROM THE INITIAL REPORTER ON VARIOUS OCCASIONS. INFORMATION WAS REQUESTED BY E-MAIL ON THE FOLLOWING DATES: 05/07/2021, 05/13/2021, 05/20/2021, AND 05/25/2021. INITIAL REPORTER HAS NOT RESPONDED TO ANY OF THE E-MAILS SENT. SSCOR ALSO ATTEMPTED TO CONTACT THEM BY PHONE ON TWO OCCASIONS BUT WAS UNSUCCESSFUL. PER THE INFORMATION RECEIVED BY THE INITIAL REPORTER, THERE WAS NO INJURY OR DEATH INVOLVED. AT THIS POINT, SSCOR IS UNABLE TO CONDUCT A FULL INVESTIGATION UNLESS WE RECEIVE ADDITIONAL INFORMATION. SSCOR WILL CONTINUE TO MONITOR THE ISSUE AND ATTEMPT TO OBTAIN ADDITIONAL INFORMATION ON THE EVENT REPORTED.

    Description of Event or Problem · 1

    "THE AMBULANCE WAS OUT ON A RUN, THEY ATTEMPTED TO USE THE UNIT AND IT DIDN'T WORK, THEY HAD A 2ND UNIT IN ANOTHER VEHICLE, USED THAT INSTEAD. UPON RETURN TO BAY, BATTERY WAS REPLACED AND THE UNIT WORKED. CUSTOMER JUST NEEDS THIS TO BE REPLACED AS IT WAS A NEW PURCHASE (B)(6) 2021. THANK YOU."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795234 SSCOR S-SCORT III JCX SSCOR INC. 74000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1