BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODES, ADULT, G5 AED

    MDR report key: 9856846 · Received March 19, 2020

    Report

    Report Number
    2112020-2020-00146
    Event Type
    Malfunction
    Date Received
    March 19, 2020
    Report Date
    February 27, 2020
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ELECTRODE PADS WERE RETURNED, UNOPENED IN THE ORIGINAL PACKAGING, TO ZOLL MEDICAL CORPORATION; THE CUSTOMER'S REPORT WAS DUPLICATED AND ATTRIBUTED TO THE RETURNED PADS. THE PACKAGING HAD NO TEARS BUT APPEARED TO BE A BIT MISSHAPEN INDICATING THEY WERE POSSIBLY EXPOSED TO HEAT. THE ELECTRODE PADS WERE SCRAPPED AND A SET OF REPLACEMENT PADS WERE SENT TO THE CUSTOMER. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE ASSOCIATED DEFIBRILLATOR DISPLAYED A "CHECK PADS" MESSAGE USING THESE ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317521 ELECTRODES, ADULT, G5 AED ELECTRODE MKJ CARDIAC SCIENCE CORPORATION XELAED001B 180417-11

    Patients

    Seq Age Sex Outcome Treatment
    1