BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R SERIES

    MDR report key: 21733533 · Received March 31, 2025

    Report

    Report Number
    1220908-2025-01060
    Event Type
    Injury
    Date Received
    March 31, 2025
    Date of Event
    March 4, 2025
    Report Date
    March 10, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION; INSTEAD, THE ACTIVITY LOG AND DEVICE CHECK LOG WERE PROVIDED FOR REVIEW. THE ACTIVITY LOG RECORDED A "DEFIB PAD SHORT" MESSAGE, THE ELECTRODES WERE MOST LIKELY STILL IN A SHORTED CONDITION AND NOT ATTACHED TO A PATIENT. BY DESIGN, AUTOMATIC AND MANUAL 30J SELF-TESTS CAN ONLY BE PERFORMED INTO A SHORT (EFFECTIVELY 0 - 15 OHMS). THE R SERIES CAN BE SHORTED BY ATTACHING THE FOLLOWING TO THE MFC: UNOPENED ZOLL DEFIB ELECTRODES WITH AN INTACT SHORTING WIRE, EXTERNAL PADDLES (WHILE IN THE WELLS), OR BY ATTACHING THE MFC TO THE SHORTED TEST PORT ON THE SIDE OF THE DEVICE. WHEN DEFIBRILLATION ELECTRODES ARE OPENED AND ATTACHED TO A PATIENT'S BODY, THE MEASURED IMPEDANCE IS GENERALLY GREATER THAN 40 OHMS. BASED ON THE EVIDENCE FROM THE DEVICE LOG, THERE IS NO EVIDENCE THAT A SHOCK WAS DELIVERED FROM THE R SERIES. 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 AND GENDER UNKNOWN), THE DEVICE INAPPROPRIATELY PERFORMED AN AUTOMATIC DAILY TEST AND DISCHARGED WHILE ON A CONSCIOUS PATIENT. COMPLAINANT INDICATED THE PATIENT AWOKE FROM THE DISCOMFORT BUT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912491 R SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 30000001001110052 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other