BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES

    MDR report key: 22543896 · Received July 18, 2025

    Report

    Report Number
    1220908-2025-02614
    Event Type
    Malfunction
    Date Received
    July 18, 2025
    Date of Event
    June 26, 2025
    Report Date
    June 30, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946019693
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE, AND THE CUSTOMER'S REPORT WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING, WHICH INCLUDED BENCH HANDLING DURING SIGNAL ACQUISITION THROUGH PADS AND SUBSEQUENT DISCHARGE, AND DEFIB CYSCLING WITHOUT DUPLIATING THE CUSTOMER'S REPORT. THE DEVICE PASSED ALL TESTING, WAS RECERTIFIED, AND RETURNED TO THE CUSTOMER. 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 DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277589 R SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 30001009001310012 NA 00847946019693

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown