BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AW 4.3 ADVANTAGE SIM

    MDR report key: 1854011 · Received September 2, 2010

    Report

    Report Number
    9611343-2010-00009
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 5, 2010
    Manufacturer
    GE MEDICAL SYSTEMS S.C.S.
    Product Code
    KPG
    PMA / PMN Number
    K052345
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE HAS INITIATED AN INVESTIGATION OF THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN NOTICED THAT THE FIDUCIAL MARKERS SHOWN IN THE ADVANTAGE SIM'S DIGITALLY RECONSTRUCTED RADIOGRAPH (DRR) WERE MISALIGNED WITH THE PT'S ANATOMY. AT THAT TIME, THE PT WAS BEING SET UP ON THE TREATMENT DELIVERY TABLE. THERE WAS NO INJURY REPORTED. THE ISSUE'S CONCERN IS FOR A POTENTIAL MISDIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AW 4.3 ADVANTAGE SIM KPG GE MEDICAL SYSTEMS S.C.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK