BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE MEDICAL SYSTEMS

    MDR report key: 520793 · Received March 31, 2004

    Report

    Report Number
    MW1031731
    Event Type
    Malfunction
    Date Received
    March 31, 2004
    Date of Event
    March 23, 2004
    Report Date
    March 31, 2004
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    IZH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COMPRESSION PADDLE DID NOT RELEASE DURING STUDY AT IMAGING CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE MEDICAL SYSTEMS GE SENOGRAPHE IZH GE MEDICAL SYSTEMS SENOGRAPHE800T *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR