BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACT 47

    MDR report key: 590841 · Received April 8, 2005

    Report

    Report Number
    1034973-2005-00001
    Event Type
    Malfunction
    Date Received
    April 8, 2005
    Date of Event
    March 10, 2005
    Report Date
    March 10, 2005
    Manufacturer
    CTI PET SYSTEMS, INC.
    Product Code
    KPS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE PREVENTATIVE MAINTENANCE ON A PET MOBILE COACH, THE SERVICE ENGINEER DISCOVERED INTERNAL WEAR AND TWO BROKEN SCREWS IN THE VERTICAL MOTOR MOUNT, WHICH IS AT THE BASE OF THE PT HANDLING SYSTEM (PHS). CPS HAS INVESTIGATED THIS PROBLEM AND FOUND THAT THE SUPPORT SCREWS ON TEH PHS VERTICAL MOTOR MOUNT CAN BECOME LOOSE OVER TIME DUE TO INCREASED VIBRATION. THIS PROCESS THEN CAUSES STRESS AND BREAKAGE IN OTHER MOUNTING SCREWS. THIS WEAR AND BREAKAGE COULD POTENTIALLY CAUSE THE PHS TO FALL. A BED SUPPORT IS REQUIRED WHILE THE SYSTEM IS IN TRANSIT. THIS REDUCES STRESS AND VIBRATION ON THE PHS WHILE THE MOBILE COACH IS IN TRANSIT. IT IS UNK WHETHER THIS CUSTOMER HAD PROPERLY UTILIZED THE BED SUPPORT, WHICH COULD HAVE CONTRIBUTED TO THE PROBLEM. NO INJURIES HAVE BEEN REPORTED TO CPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACT 47 PET SCANNER KPS CTI PET SYSTEMS, INC. 3600088-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other