BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 2070864 · Received April 15, 2011

    Report

    Report Number
    1220908-2011-01216
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 28, 2011
    Manufacturer
    ZOLL MEDICAL CORP
    Product Code
    MKJ
    PMA / PMN Number
    K060559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A (B)(6) MALE PT IN CARDIAC ARREST, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR