BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODES, ONESTEP COMPLETE, SINGLE, R SERIES

    MDR report key: 22460923 · Received July 9, 2025

    Report

    Report Number
    1218058-2025-00110
    Event Type
    Malfunction
    Date Received
    July 9, 2025
    Date of Event
    June 17, 2025
    Report Date
    June 19, 2025
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SOME INFORMATION WAS NOT PROVIDED AND IS UNKNOWN; THEREFORE, A COMPLETE UDI CANNOT BE PROVIDED. ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE ELECTRODES WERE NOT RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE ELECTRODES WERE REPORTED TO HAVE CAUSED THE SKIN TEAR DURING REMOVAL AND DID NOT ADHERE PROPERLY TO THE PATIENT. NO LOT NUMBER, PHOTOGRAPHS, OR SUPPORTING EVIDENCE WERE PROVIDED, AND THE ELECTRODES WERE DISPOSED OF AT THE CUSTOMER'S SITE. NO RETAIN SAMPLE TESTING FOR THIS LOT COULD BE PERFORMED BASED ON THE LACK OF INFORMATION PROVIDED. USERS ARE REMINDED TO FOLLOW THE IFU (8900-0224-01, ONESTEP COMPLETE EN - REV M) FOR PROPER SKIN PREPARATION AND ELECTRODE APPLICATION, WHICH INCLUDES: REMOVING CHEST HAIR, CLEANING AND DRYING THE SKIN, WIPING EXCESS MOISTURE, AND ROLLING THE ELECTRODE FROM ONE EDGE TO THE OTHER TO ENSURE SECURE ADHESION AND MINIMIZE THE RISK OF SKIN INJURY.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A 20-YEAR-OLD MALE PATIENT, THE ELECTRODE PADS WOULD NOT ADHERE TO THE PATIENT'S SKIN. 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
    150818 ELECTRODES, ONESTEP COMPLETE, SINGLE, R SERIES ELECTRODE MKJ BIO-DETEK INCORPORATED 8900-0224-01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Male