BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCN+

    MDR report key: 322871 · Received March 22, 2001

    Report

    Report Number
    9615767-2001-00006
    Event Type
    Malfunction
    Date Received
    March 22, 2001
    Date of Event
    February 25, 2001
    Report Date
    March 21, 2001
    Manufacturer
    GE MEDICAL SYSTEMS EUROPE
    Product Code
    IZI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO GEMS THAT UNDER CERTAIN CONDITIONS, NO FLUORO IMAGES COULD BE GENERATED, EVEN THOUGH X-RAY WAS ON. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12649 LCN+ DIAGNOSTIC X-RAY IZI GE MEDICAL SYSTEMS EUROPE 2224559 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA