BEUDAMED
    FDA Adverse Event Death Summary report: N

    AED PLUS

    MDR report key: 21977034 · Received May 7, 2025

    Report

    Report Number
    1220908-2025-01731
    Event Type
    Death
    Date Received
    May 7, 2025
    Date of Event
    April 16, 2025
    Report Date
    April 30, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER'S REPORT OF ELECTRODE DAMAGED DURING REMOVAL WAS CONFIRMED BY A PICTURE PROVIDED BY THE CUSTOMER. THE IMAGE SHOWED THE LEFT ANTERIOR ELECTRODE WITH EXPOSED COMPONENTS. HOWEVER, THERE IS NO UNDERSTANDING IF THE PACKAGING WAS OPENED IN ACCORDANCE WITH THE PACKAGING ILLUSTRATIONS AS WELL AS HOW THE PADS WERE REMOVED FROM THE STYRENE. THE ELECTRODES WERE NOT RETURNED AND HAVE BEEN CONFISCATED BY LOCAL AUTHORITIES PREVENTING A LOT NUMBER VERIFICATION. NO RETAIN SAMPLE DEVICE HISTORY REVIEW COULD BE PREFORMED. THE ZOLL AED PLUS WAS CONFIRMED TO FUNCTION AS INTENDED, PROVIDING AUDIBLE AND VISUAL PROMPTS DURING SHOCK DELIVERY. LOG REVIEW SHOWED THAT THREE SHOCKS WERE DELIVERED AND ALL ADVISORY PROMPTS WERE ISSUED PROPERLY. THE DEVICE PASSED TESTING SUCCESSFULLY. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    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 DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL MEDWATCH REPORT IS CORRECTING INFORMATION SUBMITTED ON THE PREVIOUS MEDWATCH REPORTS. PLEASE REFERENCE SECTION E1 (COUNTRY).

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A 38-YEAR-OLD FEMALE PATIENT, THE ELECTRODE PADS WERE DAMAGED DURING REMOVAL FROM THE PACKAGING, THE PADS WERE APPLIED TO THE PATIENT, AND THE CLINICIAN SUSTAINED AN ELECTRICAL SHOCK FROM THE DEVICE WHILE PERFORMING CPR. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED. COMPLAINANT INDICATE THAT THERE WAS NO FURTHER DAMAGE AFTER A SHORT STAY IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470120 AED PLUS DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION 20000700500011080 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Death