BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO PADZ

    MDR report key: 24746833 · Received March 31, 2026

    Report

    Report Number
    1218058-2026-00046
    Event Type
    Malfunction
    Date Received
    March 31, 2026
    Report Date
    March 11, 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
    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.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), A SPARK WAS EMITTED FROM THE PADS. COMPLAINANT INDICATED THAT THE PATIENT SUSTAINED MINOR SKIN BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558061 PRO PADZ ELECTRODES MKJ BIO-DETEK INCORPORATED 8900-4006 0426 00847946016661

    Patients

    Seq Age Sex Outcome Treatment
    1