BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITRAK XT HOLTER

    MDR report key: 23335138 · Received October 20, 2025

    Report

    Report Number
    23335138
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    August 26, 2025
    Report Date
    September 23, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    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

    COWORKER REACHED OUT TO ME. PATIENT RETURN HOLTER TO THE [REDACTED] OFFICE. WHEN THEY WENT TO DOWNLOAD IT, THE HOLTER DISPLAYED AN ERROR MESSAGE. WE WERE UNABLE TO DOWNLOAD THE HOLTER AND SEE THE REORDERED INFORMATION. BILLERS WERE ASKED TO CREDIT THE HOOK-UP, ORDERING MD WAS ASKED IF THEY WANT THE HOLTER REPEATED. HOLTER WAS PULLED FROM SERVICE AND SENT FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320326 DIGITRAK XT HOLTER ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) MWJ PHILIPS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female