BEUDAMED
    FDA Adverse Event Other Summary report: N

    ECAT EXACT

    MDR report key: 433711 · Received December 17, 2002

    Report

    Report Number
    1034973-2002-00001
    Event Type
    Other
    Date Received
    December 17, 2002
    Date of Event
    September 24, 2002
    Report Date
    December 16, 2002
    Manufacturer
    CTI PET SYSTEMS, INC.
    Product Code
    JAK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON THE DAY OF THE EVENT, TECHNOLOGIST WAS STARTING TO ALIGN THE BED TO START THE SCAN. THEY FOUND THE PATIENT NEEDED TO MOVE A FEW INCHES ON THE BED TOWARD THE GANTRY. THE PATIENT, WAS UNABLE TO DO THIS THEMSELF, SO THE TECH WENT AROUND TO THE REAR OF THE GANTRY TO PULL ON THE PATIENT PALLET COVER SHEET TO MOVE THE PATIENT DOWN THE BED/PALLET. WHILE JERKING AND PULLING ON THE SHEET, THE BED'S MOTION CONTROLLER WENT INTO SHUTDOWN MODE. THIS RELEASED THE PALLET BRAKE/CLUTCH AND CAUSED A QUICK JERK BACKWARDS OF THE BED, WHICH CAUSED THE TECH TO STRAIN THEIR BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECAT EXACT POSITRON EMISSION TOMOGRAPHY SCANNER JAK CTI PET SYSTEMS, INC. 3600088-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other