BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 6110105 · Received November 17, 2016

    Report

    Report Number
    1220908-2016-02845
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Report Date
    October 28, 2016
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K060559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE DEVICE PERFORMED TO SPECIFICATION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. REVIEW OF THE DEVICE ACTIVITY LOGS SHOWED OCCURRENCES OF SELF-TEST FAILURE. THE REPORTED EVENT WAS ATTRIBUTED TO THE END USER USING THE INCORRECT TYPE OF ELECTRODE PADS (BASIC/PEDI PADS). THIS DEVICE IS CONFIGURED FOR CPR/MWP/COMPLETE ELECTRODE PADS. THE ELECTRODES USED WERE NOT RECEIVED AS PART OF THIS INVESTIGATION. THIS REPORT HAS BEEN ATTRIBUTED TO IMPROPER USE OF THE DEVICE BY THE END USER. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE FAILED SELF TEST. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760352 R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION R SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1