BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACT 47

    MDR report key: 611015 · Received August 25, 2004

    Report

    Report Number
    1034973-2004-00004
    Event Type
    Malfunction
    Date Received
    August 25, 2004
    Date of Event
    July 14, 2004
    Report Date
    July 21, 2004
    Manufacturer
    CTI PET SYSTEMS (CPS), INC.
    Product Code
    ---
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 0

    A MOBILE PET COACH WAS RETURNED TO CTI PET SYSTEMS, INC (CPS) FOR REPAIR. SIX OF THE SCREWS IN THE VERTICAL MOTOR MOUNT, WHICH IS AT THE BASE OF THE PT HANDLING SYSTEM (PHS), WERE FOUND TO BE SHEARED, WHILE TWO HAD COMPLETELY COME OUT. FOUR OF THE SCREWS AT THE REAR MOUNT WERE ALSO LOOSE. CPS FOUND THAT THE ROOT CAUSE OF THE FAILURE WAS DUE TO THE LACK OF A SECONDARY LOCKING DEVICE (LOCTITE) ON THE SCREWS (CONTRARY TO THE BED ASSEMBLY SPECIFICATIONS). THIS HAD ALLOWED THE SCREWS TO BECOME LOOSE, WHICH HAD PUT EXTRA STRESS ON THE OTHER SCREWS. THIS 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 COACH IS IN TRANSIT. IT IS UNCLEAR WHETHER THIS MOBILE HAD PROPERLY USED 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
    0 EXACT 47 PET SCANNER --- CTI PET SYSTEMS (CPS), INC. 3600088-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    0 UNKNOWN Other