BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENOSCAN

    MDR report key: 539319 · Received March 23, 2004

    Report

    Report Number
    1418957-2004-00002
    Event Type
    Malfunction
    Date Received
    March 23, 2004
    Date of Event
    February 19, 2004
    Report Date
    March 16, 2004
    Manufacturer
    FISCHER IMAGING CORP.
    Product Code
    IZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    TECHNOLOGIST ABORTED THE MAMMOGRAPHY PROCEDURE FOR AN UNK REASON. THE COMPRESSION PADDLE DID NOT AUTOMATICALLY RELEASE AND THE TECHNOLOGIST TRIED TO RELEASE COMPRESSION USING THE MANUAL CONTROL INSTEAD OF THE FOOT SWITCH. WHEN THIS DID NOT WORK SHE HIT THE EMERGENCY STOP SWITCH, THUS REMOVING POWER FROM THE SYSTEM. THIS DISABLED THE FOOT SWITCH. SHE THEN USED SOMETHING TO FORCE THE PADDLE UP TO RELEASE COMPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENOSCAN MAMMOGRAPHY SYSTEM IZH FISCHER IMAGING CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other