BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACS-IW

    MDR report key: 2142056 · Received May 24, 2011

    Report

    Report Number
    3003966370-2011-00004
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Report Date
    April 25, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K072986
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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

    THE CUSTOMER STATES THAT SOME OF THE REPORTS ARE MISSING VERBIAGE. THE REPORT STARTS, THEN CUTS OFF AND THEN PICKS LINES UP LATER. 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