BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL

    MDR report key: 3779641 · Received April 22, 2014

    Report

    Report Number
    3779641
    Event Type
    Injury
    Date Received
    April 22, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 22, 2014
    Manufacturer
    ZOLL MEDICAL CORP
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO OBTAIN AN INITIAL 12 LEAD EKG, THE ZOLL MONITOR HAD A FAILURE. THE PT WAS ON A 4 LEAD, AND THERE WERE NO ISSUES WITH THE MONITOR. HOWEVER, SHORTLY AFTER THE 12 LEAD CABLES WERE PLUGGED IN LEADS III, AVR, AVL AND AF MALFUNCTIONED. THE MALFUNCTIONING LEADS APPEARED TO BE REGISTERING WITH THE MONITOR AS THERE WAS A SOLID ISOELECTRIC LINE DISPLAYED ON THEM, BUT IT WAS EITHER AT THE VERY TOP OR VERY BOTTOM OF THE VIEWABLE AREA FOR THAT LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244338 ZOLL ZOLL X SERIES MKJ ZOLL MEDICAL CORP X SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other