BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

    MDR report key: 11337220 · Received February 17, 2021

    Report

    Report Number
    11337220
    Event Type
    Malfunction
    Date Received
    February 17, 2021
    Date of Event
    February 2, 2021
    Report Date
    February 8, 2021
    Manufacturer
    GE HEALTHCARE, LLC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON PUTTING THE PATIENT ON THE TABLE, THE FLUORO EQUIPMENT STOPPED WORKING. SEVERAL RADIOLOGY TECHS ATTEMPTED TO RESOLVE THE ISSUE WITHOUT SUCCESS. PATIENT WAS PLACED BACK ON STRETCHER. THE GE TECH CAME ON SITE LESS THAN 30 MINUTES AND WAS ABLE TO REPAIR THE EQUIPMENT WITHIN 1.5 HOURS. IT WAS UNCERTAIN WHAT ALL NEEDED TO BE REPAIRED, SO PATIENT WAS SENT HOME AND RESCHEDULED FOR ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY). NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233124 SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED JAA GE HEALTHCARE, LLC 240379023

    Patients

    Seq Age Sex Outcome Treatment
    1