BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINIA II 3/8 HE4

    MDR report key: 2196477 · Received July 26, 2011

    Report

    Report Number
    9613299-2011-00003
    Event Type
    Malfunction
    Date Received
    July 26, 2011
    Date of Event
    May 19, 2011
    Report Date
    July 26, 2011
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
    Product Code
    KPS
    PMA / PMN Number
    K022960
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OF THE DETECTOR HEADS ON THE INFINIA II SLID ALONG THE LATERAL AXIS AND TOWARDS THE GEAR, HITTING THE HAWKEYE DETECTION UNIT/DATA COLLECTION AND PROCESSING SYSTEM. EXAMINATION BY GE HEALTHCARE FIELD SERVICE REVEALED THAT ONE OF THE LEAD SCREWS BROKE OFF DURING TRANSITION BETWEEN HOME POSITIONS (I.E. FROM "L TO H" MODE) AFTER PATIENT USE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINIA II 3/8 HE4 COMPUTED TOMOGRAPHY X-RAY SYSTEM KPS GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

    Patients

    Seq Age Sex Outcome Treatment
    1