BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED 3

    MDR report key: 24364419 · Received February 17, 2026

    Report

    Report Number
    1220908-2026-00536
    Event Type
    Malfunction
    Date Received
    February 17, 2026
    Report Date
    January 29, 2026
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946020064
    PMA / PMN Number
    P160015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 CORPORATION. DURING THE INVESTIGATION IT WAS NOTED THAT THE REPORTED PROBLEM RELATING TO THE CANT SWITCH MODES WAS VERIFIED DUE TO A LOOSE BUTTON. THE PEDIATRIC BUTTON WAS REPLACED TO REMEDY THE PROBLEM. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. NO EMERGING TREND BASED ON SIMILAR REPORTS.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WAS UNABLE TO SWITCH MODES. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495135 AED 3 DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION 1128-001102-01 NA 00847946020064

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown