BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONE STEP PEDIATRIC CPR ELECTRODE (1 PAIR)

    MDR report key: 15828771 · Received November 18, 2022

    Report

    Report Number
    1218058-2022-00127
    Event Type
    Death
    Date Received
    November 18, 2022
    Date of Event
    October 6, 2022
    Report Date
    November 16, 2022
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    UDI-DI
    00847946023348
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL MEDWATCH REPORT IS REPORTING THE EVALUATION OF THE DEVICE. THIS SUPPLEMENTAL MEDWATCH REPORT IS ALSO UPDATING INFORMATION SUBMITTED ON THE INITIAL MEDWATCH REPORT. PLEASE REFERENCES SECTIONS D4: LOT NUMBER AND EXPIRATION DATE AND H4. EVALUATION RESULTS: THE ELECTRODE PADS WERE RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. OUR EVALUATION INDICATED THAT THE POSTERIOR PAD WITH THE BLUE LAYER OF FOAM HAD BEEN SEPERATED FROM THE BOTTOM WHITE LAYER OF FOAM. THE WHITE LAYER OF FOAM ON THE ELECTRODE PADS CONTAINS THE TIN AND GEL. THIS FAILURE WAS ATTRIBUTED TO THE ELECTRODE NOT BEING PROPERLY REMOVED FROM THE PACKAGING BY THE USER. THIS WAS ALSO CONFIRMED BY THE CUSTOMER. THE ONE-STEP PEDIATRIC CPR ELECTRODES INSTRUCTIONS FOR USE STATES: TO GRASP THE ELECTRODE FROM THE BOTTOM RED TAB AND PEEL FROM THE PLASTIC LINER. IT'S IMPORTANT TO NOTE THAT THE ELECTRODES AND DEFIBS ARE TO BE USED BY TRAINED PERSONNEL AS STATED IN LABELING. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A 4-MONTH-OLD MALE PATIENT, THE ASSOCIATED DEVICE WAS UNABLE TO OBTAIN AND ECG SIGNAL USING THESE ELECTRODE PADS. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229154 ONE STEP PEDIATRIC CPR ELECTRODE (1 PAIR) ELECTRODE MKJ BIO-DETEK INCORPORATED 8900-000219-01 4121B 00847946023348

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Male Death