BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMEGA IV TABLE

    MDR report key: 1061931 · Received June 16, 2008

    Report

    Report Number
    9611343-2008-00031
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    May 21, 2008
    Report Date
    June 16, 2008
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    IZI
    PMA / PMN Number
    K052412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLE VERTICAL DRIVE MOTOR BRAKE FAILED WHILE A PT WAS ON THE TABLE DURING THE END OF AN EXAM. THE TABLE TOP REPORTEDLY DESCENDED TO ITS LOW END STOP. THE MOTOR DRIVE COULD STILL RAISE THE TABLE TOP HEIGHT BUT IT IMMEDIATELY DESCENDED AGAIN WHEN THE MOTOR DRIVE WAS STOPPED. NO PT 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

    Patients

    Seq Age Sex Outcome Treatment
    1