BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE STEP PEDIATRIC CPR ELECTRODE

    MDR report key: 19527181 · Received June 13, 2024

    Report

    Report Number
    1218058-2024-00061
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    May 23, 2024
    Report Date
    May 24, 2024
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL MEDWATCH REPORT IS REPORTING THE EVALUATION OF THE DEVICE AND CORRECTING INFORMATION SUBMITTED ON THE INITIAL MEDWATCH REPORT. PLEASE REFERENCE SECTIONS D4 CATALOG # REMOVED AND D4 PRIMARY UDI # UPDATED, THIS DEVICE HAS A UDI; SOME INFORMATION WAS NOT PROVIDED AND IS UNKNOWN; THEREFORE, A COMPLETE UDI CANNOT BE PROVIDED. THE ONE STEP CPR ELECTRODES WERE RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. DURING THE INVESTIGATION OF THE PADS TO DETERMINE THE ROOT CAUSE, THE TECHNICIAN OBSERVED DAMAGE TO THE PADS CONSISTENT WITH MISHANDLING. THE DAMAGE APPEARS TO BE CAUSED BY REMOVING THE ELECTRODE PADS FROM THE PACKAGING NOT USING THE DESIGNATED TABS AS ILLUSTRATED ON THE PACKAGE LABEL. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), A WIRE HAD BECOME DISLODGED FROM THE ELECTRODE PAD. 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
    864137 ONE STEP PEDIATRIC CPR ELECTRODE AUTOMATED EXTERNAL DEFIBRILLATOR MKJ BIO-DETEK INCORPORATED 8900-000219-01 4623A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown