BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACS SERVER

    MDR report key: 2092528 · Received April 29, 2011

    Report

    Report Number
    3004526608-2011-00016
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Report Date
    April 14, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K043415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 DURING THEIR OWN TESTING, THE MEASUREMENTS SHOWN ON AN IMAGE WERE INCORRECT. THE MEASURED VALUE WAS TWICE WHAT IT SHOULD HAVE BEEN. THERE WAS REPORTED PT 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