BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION 500D

    MDR report key: 1191925 · Received October 1, 2008

    Report

    Report Number
    2126677-2008-00076
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 4, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    JAA
    PMA / PMN Number
    K011624
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE FIELD ENGINEER INVESTIGATED THE PRECISION 500D SYSTEM AND NOTICED THAT THE SOFTWARE ANGULATION LIMITS NEEDED TO BE RE-CALIBRATED TO ENSURE THAT THE TABLETOP RETRACKS AS REQUIRED DURING ANGULATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLETOP COLLIDED WITH THE FLOOR WHILE IT WAS BEING ANGULATED TO AN 88-DEGREE POSITION. THERE WAS NO INJURY REPORTED. THE CONCERN IS FOR A SERIOUS INJURY IF THE OPERATOR'S FOOT WERE TO BECOME TRAPPED AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION 500D JAA GE MEDICAL SYSTEMS, LLC 2305472 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA