BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO-PADZ

    MDR report key: 25135140 · Received May 11, 2026

    Report

    Report Number
    1218058-2026-00064
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Report Date
    April 22, 2026
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    UDI-DI
    00847946016661
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE CARDIOVERTING A MALE PATIENT (AGE UNKNOWN), SPARKS WERE EMITTED FROM THE PADS DURING DISCHARGE. 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
    220200 PRO-PADZ ELECTRODE MKJ BIO-DETEK INCORPORATED 8900-4006 0426 00847946016661

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male