BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LU-A VASCULAR X-RAY SYSTEM

    MDR report key: 217894 · Received April 1, 1999

    Report

    Report Number
    2126677-1999-00006
    Event Type
    Malfunction
    Date Received
    April 1, 1999
    Date of Event
    March 4, 1999
    Report Date
    April 1, 1999
    Manufacturer
    GENERAL ELECTRIC MEDICAL SYSTEMS
    Product Code
    IZI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO GE THAT THE COUNTER-WEIGHT CABLES HOLDING THE IMAGE TUBE/PHOTOSPOT CAMERA FAILED, CAUSING THE IMAGE INTENSIFIER II TO FALL. THE II STOPPED AT THE MECHANICAL LIMIT. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LU-A VASCULAR X-RAY SYSTEM DIAGNOSTIC X-RAY IZI GENERAL ELECTRIC MEDICAL SYSTEMS 46-212900P1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA