BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMAGECAST PACS

    MDR report key: 3192175 · Received June 20, 2013

    Report

    Report Number
    3004526608-2013-00003
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Report Date
    May 21, 2013
    Manufacturer
    GE HEALTHCARE INTEGRATED IT SOLUTIONS
    Product Code
    LLZ
    PMA / PMN Number
    K052618
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PT DATA NOT CURRENTLY AVAILABLE. DATE OF MANUFACTURE UNK. A F/U REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE MEASUREMENTS FROM THE SIEMENS MODALITY ARE INCORRECT. THERE WAS NO REPORTED PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281128 IMAGECAST PACS LLZ GE HEALTHCARE INTEGRATED IT SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1