BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACS IW

    MDR report key: 2271980 · Received September 28, 2011

    Report

    Report Number
    3004526608-2011-00048
    Event Type
    Malfunction
    Date Received
    September 28, 2011
    Report Date
    August 31, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K072986
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A F/U REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT WHEN FLIPPING AN IMAGE ON A SUPINE ANKLE, PACS-IW IS NOT BURNING THE CORRECT DISPLAY PRESENTATION ON THE CD. THERE WAS NO REPORTED PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACS IW LLZ GE HEALTHCARE PACS-IW-150 NA

    Patients

    Seq Age Sex Outcome Treatment
    1