BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E SERIES DEFIBRILLATOR

    MDR report key: 3856385 · Received April 9, 2014

    Report

    Report Number
    1220908-2014-00923
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 31, 2014
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K042007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MED 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 TREAT A PT (AGE & GENDER UNK) THE DEVICE INAPPROPRIATELY SHUT DOWN. 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
    214128 E SERIES DEFIBRILLATOR E SERIES MKJ ZOLL MEDICAL CORPORATION E SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK