BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.2 SENO ADVANTAGE WORKSTATION

    MDR report key: 1592825 · Received January 26, 2010

    Report

    Report Number
    9611343-2010-00004
    Event Type
    Malfunction
    Date Received
    January 26, 2010
    Date of Event
    January 13, 2010
    Report Date
    January 13, 2010
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    LLZ
    PMA / PMN Number
    K033400
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 2.2 SENO ADVANTAGE SYSTEM PERFORMED A TRUE SIZE PRINTING WITH INCORRECT SCALE ANNOTATION. A GE CLINICAL SPECIALIST WAS CONDUCTING TRAINING FOR 2.2 SENO ADVANTAGE SYSTEM AT A CUSTOMER SITE. DURING THE TRAINING, THE SPECIALIST SELECTED TRUE SIZE OPTION TO PRINT THE IMAGE. THE IMAGE ON THE SCREEN WAS ANNOTATED TO A SCALE OF 1.00. WHEN THE IMAGE WAS PRINTED USING THE PRINT ORIGINAL TOOL, THE SPECIALIST NOTICED THAT THE SCALE ANNOTATED ON THE HARD COPY WAS 1.67. THERE WAS NEITHER PT INVOLVEMENT NOR INJURY REPORTED. THE CONCERN IS THAT HEALTHCARE PROFESSIONALS COULD MAKE INCORRECT MEASUREMENTS BASED ON THE SCALE WHEN PLANNING A SURGERY OR BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.2 SENO ADVANTAGE WORKSTATION LLZ GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1