BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 6135114 · Received November 30, 2016

    Report

    Report Number
    1220908-2016-02942
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Report Date
    November 9, 2016
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K060559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL (B)(4); THE MALFUNCTION WAS OBSERVED AND THE DIGITAL BOARD WAS REPLACED TO REMEDY THE PROBLEM. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. THE DIGITAL BOARD WAS RETURNED TO ZOLL MEDICAL US; THE MALFUNCTION WAS DUPLICATED AND ATTRIBUTED TO A FAULTY INTEGRATED CIRCUIT ON THE DIGITAL BOARD. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WAS UNABLE TO SWITCH MODES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787863 R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION R SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1