BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLUOROSCOPY X RAY MACHINE

    MDR report key: 16876127 · Received May 5, 2023

    Report

    Report Number
    MW5117236
    Event Type
    Death
    Date Received
    May 5, 2023
    Report Date
    April 29, 2023
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2021, MY MOTHER, (B)(6) DOB (B)(6) 1948, WENT TO (B)(6) HOSPITAL IN (B)(6) FOR A HEART CATHETERIZATION. DURING THE OPERATION, THE FLUOROSCOPY X RAY MACHINE WENT DOWN SEVERAL TIMES AND WAS NOT ABLE TO BE REBOOTED. MY MOTHER HAD TO BE MOVED TO ANOTHER ROOM IN ORDER TO USE ANOTHER FLUOROSCOPY MACHINE. WHEN THEY WERE ABLE TO GET AN IMAGE, MY MOTHER'S ARTERY HAD BEEN SEVERED AND SHE BLED TO DEATH. (B)(6) WAS SUPPOSED TO HAVE THIS MACHINE CONFISCATED AND REPORT THIS DEATH TO THE FDA, WHICH THEY ADMITTED THAT THEY DID NOT DO. THIS X-RAY MACHINE IS STILL IN (B)(6) HOSPITAL AND THERE IS NO TELLING HOW MANY MORE DEATHS HAVE BEEN CAUSED BECAUSE OF THIS MACHINE AND (B)(6) CRIMINAL ACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468331 FLUOROSCOPY X RAY MACHINE SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED JAA GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death