BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES

    MDR report key: 21984255 · Received May 8, 2025

    Report

    Report Number
    1220908-2025-01533
    Event Type
    Malfunction
    Date Received
    May 8, 2025
    Report Date
    April 17, 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

    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.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CANADA FOR EVALUATION. THE CUSTOMER'S REPORT WAS DUPLICATED AND ATTRIBUTED TO FAULTY PRIMARY ECG SHIELD, PRIMARY MFE SHIELD, SECONDARY ECG SHIELD, AND SECONDARY MFE SHIELD. THE PRIMARY ECG SHIELD, PRIMARY MFE SHIELD, SECONDARY ECG SHIELD, AND SECONDARY MFE SHIELD WERE REPLACED TO RESOLVE THE REPORT. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795095 R SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 30000000001110062 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown