BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE HEALTHCARE MAC VU360

    MDR report key: 22995798 · Received September 8, 2025

    Report

    Report Number
    MW5175727
    Event Type
    Injury
    Date Received
    September 8, 2025
    Date of Event
    May 13, 2025
    Report Date
    September 3, 2025
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    DPS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    CLINICAL ATTEMPTED TO TAKE EKG OF PATIENT. THEY WERE UNABLE TO GET A READING AND RECEIVED MESSAGE ON MACHINE "ACQUISITION MODULE IS DISCONNECTED." ATTEMPTED TO UNPLUG AND RESET ACQUISITION MODULE. CLINICIAN TRIED AGAIN AND THE LEADS STARTED BECOMING HOT/BURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2497451 GE HEALTHCARE MAC VU360 ELECTROCARDIOGRAPH DPS GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. MAC VU360

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention