BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITRAK XT

    MDR report key: 22564237 · Received July 22, 2025

    Report

    Report Number
    22564237
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    July 7, 2025
    Report Date
    July 17, 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

    PATIENT'S MOTHER CALLED A LEFT A MESSAGE ON THE CARD TECH PHONE LINE. A FEW HOURS AFTER WEARING THE HOLTER MONITOR, THE HOLTER DISPLAYED A ERROR MESSAGE OF DEFECTIVE CARD. HOLTER WAS WORKING WHEN APPLIED. I E- MESSAGED ORDERING MD TO SEE IF THEY WANT THE HOLTER REPEATED. MESSAGED THE BILLERS TO NOT BILL FOR THE HOOK-UP CHARGE. HOLTER WILL BE SENT IN FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1785275 DIGITRAK XT ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) MWJ PHILIPS MEDICAL SYSTEMS DIGITRAK XT HOLTER RECORDER

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male