BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMEGA IV TABLE

    MDR report key: 1071656 · Received July 10, 2008

    Report

    Report Number
    9611343-2008-00034
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    June 13, 2008
    Report Date
    July 10, 2008
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    IZI
    PMA / PMN Number
    K052412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN TRANSFERRING A PATIENT FROM THE GURNEY TO TABLE, THE ROTATIONAL LOCK SLIPPED. NO PATIENT INJURY WAS REPORTED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMEGA IV TABLE VASCULAR X-RAY SYSTEM IZI GE MEDICAL SYSTEMS SCS 2243720

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR