BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCEL

    MDR report key: 611262 · Received May 27, 2005

    Report

    Report Number
    1034973-2005-00003
    Event Type
    Malfunction
    Date Received
    May 27, 2005
    Date of Event
    April 27, 2005
    Report Date
    April 28, 2005
    Manufacturer
    CTI PET SYSTEMS, INC.
    Product Code
    KPS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING TRANSIT OF A MOBILE PET SYSTEM, THE PATIENT HANDLING SYSTEM (PHS) COLLAPSED. CPS HAS INVESTIGATED THIS PROBLEM AND FOUND THAT THE SUPPORT SCREWS ON THE PHS VERTICAL MOTOR MOUNT CAN BECOME LOOSE OVER TIME DUE TO INCREASED VIBRATION. THIS PROCESS THEN CAUSES STRESS AND BREAKAGE IN OTHER MOUNTING SCREWS. TWO BED SUPPORTS ARE REQUIRED TO BE USED WHILE THE SYSTEM IS IN TRANSIT. THIS REDUCES STRESS AND VIBRATION ON THE PHS WHILE THE MOBILE COACH IS IN TRANSIT. THIS MOBILE PROVIDER WAS NOT USING THE REQUIRED BED SUPPORTS, WHICH LIKELY CONTRIBUTED TO THIS PROBLEM. NO INJUIRIES HAVE BEEN REPORTED TO CPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCEL PET SCANNER KPS CTI PET SYSTEMS, INC. 3600211-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other