BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LFX GENERATOR

    MDR report key: 179784 · Received July 27, 1998

    Report

    Report Number
    2126677-1998-00023
    Event Type
    Malfunction
    Date Received
    July 27, 1998
    Date of Event
    April 30, 1998
    Report Date
    July 27, 1998
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    IZO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO GE THAT PATIENTS EXPERIENCED HAIR LOSS AFTER FLUOROSCOPIC HEAD PROCEDURES ON THE DIAGNOSTIC X-RAY FLUOROSCOPIC SYSTEM. THE EXAMS WERE CONDUCTED ON OR ABOUT 26 FEB 1998 AND 10 MAR 1998. A MALFUNCTION OF THE HV CONTROL MAY HAVE CONTRIBUTED TO THE EVENT. THE EQUIPMENT HAS BEEN REPAIRED AND RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LFX GENERATOR DIAGNOSTIC X-RAY IZO GE MEDICAL SYSTEMS 46-275911GB NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *