BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES

    MDR report key: 22115115 · Received May 30, 2025

    Report

    Report Number
    1220908-2025-01835
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Report Date
    May 9, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CANADA EVALUATED THE DEVICE AND THE CUSTOMER'S REPORT WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING, WHICH INCLUDED FUNCTIONAL TESTING WITHOUT DUPLICATING THE REPORT. THE PRMARY ECG SHIELD, PRIMARY MFE SHIELD, SECONDARY ECG SHIELD, AND SECONDARY MFE SHIELD WERE REPLACED AS A PRECAUTION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED LEAKAGE CURRENT TESTING. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26487 R SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 30001001001110262 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown