BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMICAS LIGHT BEAM WORKSTATION 1.0

    MDR report key: 1180814 · Received September 23, 2008

    Report

    Report Number
    1225690-2008-00001
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    May 2, 2007
    Report Date
    May 2, 2007
    Manufacturer
    AMICAS, INC.
    Product Code
    LLZ
    PMA / PMN Number
    K022970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IMPACTED CLIENT SITES ARE UPGRADED TO REPAIRED VERSION OF DEVICE. THE MDR IS SUBMITTED LATE, AS IT WAS ENCOUNTERED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS. COMPLAINT PROCEDURE HAS BEEN REVISED AND STAFF RETRAINED TO AVOID REOCCURRENCE OF DELAY.

    Description of Event or Problem · 1

    PACS SOFTWARE IMAGING DEVICE FETCHED A WRONG PRIOR IMAGE FOR COMPARISON PURPOSES BASED ON NAME, DATE OF BIRTH AND GENDER (CHECK OF IDENTICAL DATE OF BIRTH AND GENDER FAILED). DOCTOR REALIZED THE ISSUE IMMEDIATELY THANKS TO LABELING. PT. UNHURT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMICAS LIGHT BEAM WORKSTATION 1.0 LLZ AMICAS, INC. 4.1 CU7

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR