BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCOVERY 750HD

    MDR report key: 25147788 · Received May 12, 2026

    Report

    Report Number
    25147788
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    April 22, 2026
    Report Date
    April 28, 2026
    Manufacturer
    GE MEDICAL SYSTEMS, L.L.C.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WAS ON THE CT TABLE, AND THE EXAM WAS ABOUT TO BEGIN WHEN THE SCANNER SUDDENLY BEGAN MAKING A LOUD NOISE. SHORTLY AFTER, INTERNAL COMPONENTS ERUPTED FROM THE TOP OF THE GANTRY. THE GANTRY COVERING BECAME DAMAGED AND PARTIALLY DETACHED. A SIGNIFICANT AMOUNT OF OIL BEGAN LEAKING FROM THE TOP OF THE MACHINE. THE SCAN WAS IMMEDIATELY STOPPED AND THE PATIENT WAS PROMPTLY/SAFELY REMOVED FROM THE TABLE. MANUFACTURER RESPONSE FOR COMPUTED TOMOGRAPHY (CT) SCANNER, DISCOVERY 750HD 64SLICE + 9355 14KVA (PER SITE REPORTER). THEY ARE COMPLETING AN INVESTIGATION AND ROOT CAUSE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525838 DISCOVERY 750HD SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK GE MEDICAL SYSTEMS, L.L.C.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other