BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITRAK XT HOLTER RECORDER W/LEADWIRES

    MDR report key: 8522209 · Received April 17, 2019

    Report

    Report Number
    8522209
    Event Type
    Malfunction
    Date Received
    April 17, 2019
    Date of Event
    March 27, 2019
    Report Date
    April 2, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC.
    Product Code
    MWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    24 HOUR HOLTER MONITOR WAS APPLIED TO THE PATIENT. BEFORE PATIENT LEFT THE OFFICE, NAME AND ECG TRACINGS WERE RECORDING AS USUAL. UPON HOLTER RETURN AND DOWNLOADING, NO ECG TRACINGS WERE NOTED ON THE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315110 DIGITRAK XT HOLTER RECORDER W/LEADWIRES ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS) MWJ PHILIPS MEDICAL SYSTEMS, INC. DIGITRAK XT

    Patients

    Seq Age Sex Outcome Treatment
    1