BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G3 PLUS AUTO, AED, ENGLISH, PKG

    MDR report key: 24769621 · Received April 2, 2026

    Report

    Report Number
    2112020-2026-00143
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    September 27, 2025
    Report Date
    September 30, 2025
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    JUSTIFICATION FOR NO UDI, THIS DEVICE WAS MANUFACTURED BEFORE UDI REQUIREMENTS. ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE PADS, DEVICE, AND EVENT LOGS WERE NOT RETURNED FOR EVALUATION. PHOTOGRAPHS OF PADS LOT # 240419-04 WERE REVIEWED AND SHOWED USED PADS WITH BROWN DISCOLORATION, FOREIGN MATERIAL, AND HAIR; HOWEVER, THE REPORTED DISCOLORED GEL COULD NOT BE CONFIRMED OR RULED OUT BASED ON THE IMAGES PROVIDED. NO CLINICAL DATA FILES WERE RECEIVED, THEREFORE, THE REPORTED ISSUE, INCLUDING WHETHER SHOCK WAS ADVISED, COULD NOT BE VERIFIED. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER, BUT NO RESPONSE WAS RECEIVED, DESPITE DUE DILLIGANT ATTEMPTS. THE INVESTIGATION WILL BE CLOSED AS NO PRODUCT RETURNED AND WILL REOPEN IF PRODUCT IS RECEIVED.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A 87-YEAR-OLD MALE PATIENT, THE DEVICE FAILED TO DISCHARGE. 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
    539226 G3 PLUS AUTO, AED, ENGLISH, PKG AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION 9390A-501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1