BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES

    MDR report key: 23143862 · Received September 25, 2025

    Report

    Report Number
    1220908-2025-03609
    Event Type
    Malfunction
    Date Received
    September 25, 2025
    Date of Event
    September 9, 2025
    Report Date
    September 12, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION. THIS DEVICE WAS MANUFACTURED BUT NOT DOMESTICALLY DISTRIBUTED; IT IS ONLY DISTRIBUTED IN THE INTENDED GEOGRAPHY. THERE IS NO EXISTING UDI REGULATION.

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL FINLAND EVALUATED THE DEVICE AND THE CUSTOMER'S REPORT WAS NOT DUPLICATED. WE SUSPECT THE MULTIFUNCTION CABLE (MFC) DAMAGE WAS A FACTOR, BUT FUNCTIONAL. THE MFC WAS REPLACED AS A PRECAUTION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ZOLL MEDICAL CORPORATION RECEIVED THE MFC USED DURING THE REPORTED EVENT. THE MFC WAS TESTED WITH A KNOWN GOOD DEVICE AND PASSED ALL FUNCTIONAL TESTING. IT'S IMPORTANT TO NOTE THE CABLE SHOULD BE VISUALLY INSPECTED AS PART RECOMMENDED DAILY VISUAL INSPECTION AND REPLACED IF DAMAGED. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE ELECTRODE PAD OF THE ASSOCIATED DEFIBRILLATOR WOULD NOT CONNECT TO THE MULTI-FUNCTION CABLE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2394339 R SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 30000000001130212 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown