BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 24884715 · Received April 15, 2026

    Report

    Report Number
    2183553-2026-00002
    Event Type
    Injury
    Date Received
    April 15, 2026
    Date of Event
    March 17, 2026
    Report Date
    April 15, 2026
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    OUO
    UDI-DI
    00840682105378
    PMA / PMN Number
    K163619
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LEGAL MANUFACTURER: HCS MR - 3200 N GRANDVIEW BLVD. USA WAUKESHA, WI 53188. D2 COMMON DEVICE NAME: TOMOGRAPHIC IMAGER COMBINING EMISSION COMPUTED TOMOGRAPHY WITH NUCLEAR MAGNETIC RESONANCE. D: THERE ARE NO ADDITIONAL DEVICE IDENTIFICATION NUMBERS. H3, 6: GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    AFTER COMPLETION OF AN EXAM, A TECHNOLOGIST TRIPPED OVER TUBING FROM THE PATIENT ALERT BALL THAT HAD EXTENDED ONTO THE SCAN ROOM FLOOR WHILE THE PATIENT WAS REMOVED FROM THE BORE OF THE SCANNER. THE TECHNOLOGIST FELL, LANDING ON THE RIGHT KNEE, STRIKING THE NOSE, AND INJURING THE LEFT SHOULDER WHILE ATTEMPTING TO BRACE THE FALL. THE TECHNOLOGIST SOUGHT MEDICAL EVALUATION AT AN URGENT CARE FACILITY THE FOLLOWING DAY AND WAS DIAGNOSED WITH A LEFT CHEST CONTUSION AND LEFT SHOULDER STRAIN, WITH SUBSEQUENT INITIATION OF PHYSICAL THERAPY. NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952828 NA TOMOGRAPHICIMAGERCOMBININGEMISSION OUO GE MEDICAL SYSTEMS, LLC SIGNA PET MR 00840682105378

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other