BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL

    MDR report key: 23253347 · Received October 9, 2025

    Report

    Report Number
    MW5177088
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    October 1, 2025
    Report Date
    October 6, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT CODED IN ASSISTED LIVING ROOM. STAFF GRABBED THE ZOLL AUTOMATED EXTERNAL DEFIBRILLATOR (AED) 3, AED AVAILABLE AND PLACED PADS ON PATIENT. AED PADS, CPR (CARDIOPULMONARY RESUSCITATION)-D-PADZ WOULD NOT ADHERE TO PATIENT. THE EXPIRATION DATE ON THE PADS ARE 5-12-2027 LOT # 0722A. PATIENT WAS NOT SWEATY, OR POWDERED, HAD FLAKY SKIN. EMERGENCY MEDICAL SERVICES (EMS) ARRIVED WITH IN A COUPLE MINUTES AND PLACED ZOLL X SERIES PADPRO CONMED HANDS FREE PADS ON PATIENT AND THEY ADHERED WITHOUT ISSUE. PATIENT WAS TRANSFERRED TO EMERGENCY ROOM (ER) AND THEN EXPIRED. AED 3 WAS TESTED PRIOR TO USE AND THEN AFTER AND WAS IN GOOD WORKING ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2617012 ZOLL AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ ZOLL MEDICAL CORPORATION AED 3 0722A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening CPR-D-PADZ.