BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDMARK DIGITAL EKG

    MDR report key: 1693410 · Received May 13, 2010

    Report

    Report Number
    MW5015965
    Event Type
    Malfunction
    Date Received
    May 13, 2010
    Date of Event
    April 22, 2010
    Report Date
    May 13, 2010
    Manufacturer
    MIDMARK
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN A PEDIATRIC SETTING, WHEN A DIGITAL ECG IS COLLECTED, IT CORRECTLY CALCULATES THE QTC WITH THE BAZETT FORMULA. IF THE CARDIOLOGIST ELECTS TO CORRECT THE QT INTERVAL BY DOUBLE CLICKING ON "QT", THEY ARE PRESENTED WITH A SCREEN "EDIT MEASUREMENT". IF THEY SELECT "OK", -EVEN WITHOUT CHANGING THE VALUE-, THE HODGES FORMULA IS AUTOMATICALLY ACTIVATED RESULTING IN AN UNINTENTIONAL CHANGE IN THE QTC RECORDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIDMARK DIGITAL EKG NONE DRT MIDMARK

    Patients

    Seq Age Sex Outcome Treatment
    1