BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA 2100 IQ

    MDR report key: 1386131 · Received March 11, 2009

    Report

    Report Number
    9611343-2009-00013
    Event Type
    Malfunction
    Date Received
    March 11, 2009
    Date of Event
    February 11, 2009
    Report Date
    March 11, 2009
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    MQB
    PMA / PMN Number
    K052412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE ROTARY JOINT FAILURE RESULTING FROM A ROTATION LOCK/JAM IS MOST PROBABLY DUE TO A MANUFACTURING SHIFT. THIS FAILURE MODE WAS REVEALED BY STIFFENER INTRODUCTION ON THE SYSTEM. THIS WAS IDENTIFIED AS AN EARLY LIFE FAILURE. THE STIFFENER WAS REMOVED FROM FORWARD PRODUCTION SYSTEMS AND WILL BE REMOVED PRIOR TO INSTALLATION FOR SYSTEMS PENDING INSTALL. FOR THE INSTALLED BASE, THE STIFFENER WILL BE REMOVED DURING CORRECTIVE MAINTENANCE OF THE WATER COUPLING SYSTEM FOR SYSTEMS ALREADY INSTALLED. AT THE SITE, THE STIFFENER ROD WAS REMOVED. THIS SITE HAS BEEN REPAIRED AND PLACED BACK INTO USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS FLUID COMING FROM THE GANTRY. FOUND ROTATING GASKET FROZEN SOLID CAUSING COPPER FLUID LINES TO TWIST AND RUPTURE. THE ROTATING COUPLING WATER JOINT IN THE C-ARC FAILED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVA 2100 IQ VASCULAR X-RAY SYSTEM MQB GE MEDICAL SYSTEMS SCS 2184070-2

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR