BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACS IW

    MDR report key: 1922579 · Received November 19, 2010

    Report

    Report Number
    3003966370-2010-00022
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Report Date
    October 20, 2010
    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 FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE IMAGES ARE NOT SHOWING RIGHT OR LEFT FOR THE EXTREMITIES. 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