BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA 2000

    MDR report key: 1396683 · Received March 17, 2009

    Report

    Report Number
    9611343-2009-00018
    Event Type
    Malfunction
    Date Received
    March 17, 2009
    Date of Event
    March 6, 2009
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    IZI
    PMA / PMN Number
    K024200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BRAKE OF THE VERTICAL DRIVE ASSEMBLY ON THE OMEGA V TABLE WAS NOT WORKING PROPERLY. THE TABLE GOES DOWN ON ITS OWN AS SOON AS POWER IS REMOVED FROM THE VERTICAL MOTOR. NO PATIENT INJURY WAS REPORTED. GE FIELD SERVICE ENGINEER FOUND THAT THE HEXAGONAL HEAD ON THE MOTOR SHAFT WAS DISENGAGED FROM THE BRAKE DISK. THE TWO SCREWS THAT SECURED THE HEXAGONAL HEAD WERE LOOSE. THE GE FIELD SERVICE ENGINEER REPLACED THE MOTOR ASSEMBLY, WHICH FIXED THE SYSTEM. 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 INNOVA 2000 VASCULAR X-RAY SYSTEM IZI GE MEDICAL SYSTEMS SCS 2320045

    Patients

    Seq Age Sex Outcome Treatment
    1