BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACS SERVER

    MDR report key: 1459226 · Received June 26, 2009

    Report

    Report Number
    3004526608-2009-00047
    Event Type
    Malfunction
    Date Received
    June 26, 2009
    Report Date
    May 27, 2009
    Manufacturer
    GE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K043415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    NUH REJECTED IMAGES NOT UPDATED WITH DATACENTER EA. THERE WAS NO REPORTED PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1