BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITRAK XT

    MDR report key: 16452038 · Received February 28, 2023

    Report

    Report Number
    16452038
    Event Type
    Malfunction
    Date Received
    February 28, 2023
    Date of Event
    November 23, 2022
    Report Date
    February 13, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS HSG
    Product Code
    MWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CARDIOLOGY TECHNICIAN ATTEMPTED TO DOWNLOAD THE HOLTER, BUT THE SOFTWARE STATED 0.0 HOURS. ATTEMPTS TO UPLOAD THE MONITOR WERE UNSUCCESSFUL THREE TIMES. THE HOLTER MONITOR DID NOT RECORD AT ALL FOR THE 48 HOURS IT WAS ORDERED AND WORN BY THE PATIENT. CARDIOLOGY TECHNICIAN CONTACTED THE ORDERING PROVIDER AND TESTING WILL BE REPEATED. PATIENT NOTIFIED AND AGREEABLE TO REDO HOLTER MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856374 DIGITRAK XT ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) MWJ PHILIPS MEDICAL SYSTEMS HSG DIGITRAK XT HOLTER RECORDER

    Patients

    Seq Age Sex Outcome Treatment
    1 18250 DA Male