BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 5257554 · Received December 1, 2015

    Report

    Report Number
    1220908-2015-03100
    Event Type
    Malfunction
    Date Received
    December 1, 2015
    Report Date
    November 11, 2015
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K060559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE REPORTED MALFUNCTION WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING WHICH INCLUDED A SIMULATOR, VFIB SIGNAL, AND NSR SIGNAL WITHOUT DUPLICATING THE MALFUNCTION. IT IS IMPORTANT TO NOTE THAT THESE DEVICES ARE DESIGNED TO DETECT AND ANALYZE PATIENT RHYTHMS. LOOPED SIGNALS FROM SIMULATORS MAY CAUSE THE DEVICE NOT TO PROPERLY DETECT SIGNAL TYPES. THEREFORE THE DEVICE MEETS SPEC. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING TRAINING BY FACILITY STAFF, THE DEVICE WAS UNABLE TO ANALYZE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786660 R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION R SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1