BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 10065653 · Received May 18, 2020

    Report

    Report Number
    1220908-2020-01409
    Event Type
    Malfunction
    Date Received
    May 18, 2020
    Report Date
    April 28, 2020
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946017163
    PMA / PMN Number
    K060559/P160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE DEVICE PERFORMED TO SPECIFICATION. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING WITHOUT DUPLICATING THE REPORT. REVIEW OF THE DEVICE LOG DOES CONFIRMED THAT THE DEVICE WAS CONFIGURED TO USE CPR/MWP/COMPLETE ELECTRODES AND THE LOG SHOWED THE DEVICE WAS CONNECTED TO EXTERNAL PADDLES AND TEST PORT WHILE PERFORMING THE AUTO READINESS TEST AND 30J MANUAL TEST. THEREFORE, ELECTRODE NOT CONNECTED MESSAGED WAS DISPLAYED. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE. IT'S IMPORTANT TO MENTION THE EXTERNAL PADDLES USED AT THE TIME OF THE REPORTED EVENT WERE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WAS UNABLE TO DETECT THE ATTACHED 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
    529973 R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION R SERIES NA 00847946017163

    Patients

    Seq Age Sex Outcome Treatment
    1