BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACS IW

    MDR report key: 2193241 · Received July 13, 2011

    Report

    Report Number
    3004526608-2011-00025
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K110875
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 SITE REPORTS THAT WHEN OPENING THE PT DOCUMENT AND GOING INTO THE PT FOLDER IN PACS, YOU GET A DIFFERENT PT DOCUMENT THAN WHAT WAS ANTICIPATED. THE STUDY CONDUCTED CONTAINS TWO DOCUMENT SEQUENCES INSTEAD OF ONE. 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 UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1