BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO-PADZ RADIOLUCENT SOLID GEL ELECTRODE, SINGLE

    MDR report key: 23791056 · Received December 12, 2025

    Report

    Report Number
    1218058-2025-00197
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    November 26, 2025
    Report Date
    December 1, 2025
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THREE PRO-PADZ RADIOLUCENT SOLID GEL ELECTRODE SETS WERE RETURNED FOR EVALUATION. TESTING SHOWED NORMAL ELECTRICAL RESISTANCE (0.3 OHMS) AND CONFIRMED AN INTACT CONDUCTIVE PATHWAY. ALL ELECTRODE SETS PASSED FUNCTIONAL AND CABLE-STRESS TESTING USING A KNOWN-GOOD DEVICE AND SIMULATOR, WITH CONTINUOUS ECG SIGNAL VISIBILITY. ENERGY DELIVERY TESTING WAS ALSO SUCCESSFUL (DEVICE CHARGED TO 200J AND DISCHARGED 200- 232 J THROUGH THE ELECTRODES). NO ABNORMALITIES WERE FOUND, AND THE CUSTOMER REPORT COULD NOT BE REPRODUCED. THE DEVICE OR CLINICAL LOG FROM THE EVENT WERE NOT AVAILABLE FOR EVALUATION. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER. THE RETURNED PRODUCT WAS SCRAPPED. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A 71-YEAR-OLD FEMALE PATIENT, THE ASSOCIATED DEFIBRILLATOR WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA THESE ATTACHED ELECTRODE PADS. THE PATIENT HAD TO BE VENTILATED WITH AN AMBU BAG AND REQUIRED FURTHER SEDATION UNTIL NEW DEFIBRILLATION PADS WERE APPLIED. 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
    105533 PRO-PADZ RADIOLUCENT SOLID GEL ELECTRODE, SINGLE DEFIB/PACING ELECTRODE MKJ BIO-DETEK INCORPORATED 8900-4006 2725A

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female