BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRICITY WEB-DX

    MDR report key: 1834442 · Received September 10, 2010

    Report

    Report Number
    3003966370-2010-00016
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Report Date
    August 13, 2010
    Manufacturer
    GE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K083018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE REPORTED DEVICE DOES NOT DISPLAY THE MAMMOGRAM EXAM CORRECTLY. THERE WAS NO REPORTED PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRICITY WEB-DX LLZ GE HEALTHCARE UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1