BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT PADZ

    MDR report key: 24162050 · Received January 23, 2026

    Report

    Report Number
    1218058-2026-00008
    Event Type
    Malfunction
    Date Received
    January 23, 2026
    Date of Event
    January 4, 2026
    Report Date
    January 6, 2026
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    UDI-DI
    00847946016456
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 STAT-PADZ ELECTRODES LOT #4425 WERE RETURNED TO ZOLL MEDICAL CORPORATION IN OPENED ORIGINAL PACKAGING. VISUAL INSPECTION FOUND THAT THE HIGH-VOLTAGE WIRES FOR BOTH PADS WERE DISCONNECTED FROM THE RING AND SOCKET CONNECTIONS. FURTHER EXAMINATION SHOWED THE WIRES HAD BEEN PULLED OUT FROM THE CONNECTION POINTS, AND TEARING WAS OBSERVED IN THE SURROUNDING FOAM. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT FINAL RELEASE PULL TESTING WAS PERFORMED ON 13 SAMPLES (26 WIRES), AND ALL MET THE MINIMUM REQUIREMENT. IN ADDITION, ALL PADS UNDERGO CONTINUITY TESTING PRIOR TO PACKAGING. BASED ON THESE RESULTS, THE DAMAGE WOULD NOT HAVE BEEN PRESENT PRIOR TO PACKAGING AND IS NOT CONSISTENT WITH NORMAL USE. THE INVESTIGAION CONCLUDED THE CUSTOMER REPORT WAS DUE TO USER MISHANDLING. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE PACING A 60-YEAR-OLD MALE PATIENT, THE ELECTRODE PADS WERE DAMAGED DURING OPENING/REMOVAL OF PACKAGING. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF PADS TO CONTINUE TREATING THE PATIENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228562 STAT PADZ ELECTRODES MKJ BIO-DETEK INCORPORATED 8900-4004 4425 00847946016456

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male