BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 4250158 · Received August 22, 2013

    Report

    Report Number
    1220908-2014-02136
    Event Type
    Malfunction
    Date Received
    August 22, 2013
    Date of Event
    July 5, 2014
    Report Date
    August 7, 2014
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    DRO
    PMA / PMN Number
    K060559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PT, THE DEVICE FAILED TO CAPTURE THE PT'S HEART RHYTHM. COMPLAINANT DID NOT INDICATED THAT THERE WAS ANY ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409697 R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER DRO ZOLL MEDICAL CORPORATION R SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK