BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AW SUITE

    MDR report key: 1381755 · Received March 16, 2009

    Report

    Report Number
    3004526608-2009-00019
    Event Type
    Malfunction
    Date Received
    March 16, 2009
    Report Date
    February 20, 2009
    Manufacturer
    GE HEALTHCARE INTEGRATED IT SOLUTIONS
    Product Code
    LLZ
    PMA / PMN Number
    K061372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AW SUITE REPORT OVERWRITES PRELIMINARY RIS REPORT. THERE WAS NO REPORTED PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AW SUITE AW SUITE RA1000 LLZ GE HEALTHCARE INTEGRATED IT SOLUTIONS UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1