BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA 2000 POSITIONER LC

    MDR report key: 521890 · Received February 6, 2004

    Report

    Report Number
    9615767-2004-00004
    Event Type
    Malfunction
    Date Received
    February 6, 2004
    Date of Event
    January 7, 2004
    Report Date
    February 6, 2004
    Manufacturer
    GE MEDICAL SYSTEMS EUROPE
    Product Code
    IZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER SAID THEY HAD JUST TAKEN THE PT OFF THE OMEGA TABLE AND ALL OF A SUDDEN THE LC GANTRY PIVOT STARTED TO SPIN TO RAO POSITION. IT HIT THE PT'S BED (NOT THE PT) AND STOPPED. THEY SAID THEY TRIED TO HIT THE EMERGENCY STOP SWITCH ON THE TSSC BUT IT DID NOT STOP THE GANTRY FROM MOVING. THE PT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVA 2000 POSITIONER LC DIAGNOSTIC X-RAY IZO GE MEDICAL SYSTEMS EUROPE 2355746 *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR