BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSHIBA X-SPEED

    MDR report key: 18787 · Received November 11, 1994

    Report

    Report Number
    18787
    Event Type
    Malfunction
    Date Received
    November 11, 1994
    Report Date
    June 10, 1994
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SOFTWARE SYSTEM UTILIZED FOR TWO (2) CT SCANNERS INCLUDES AN "ADD SCAN" FEATURE WHICH ALLOWS OPERATOR TO ADD A SCAN OF A DIFFERENT ORIENTATION TO AN EXISTING SCAN.IT AN ORIGINAL SCAN BEGINS WITH A HEAD-FOOT ORIENTATION, THE FEATURE ALLOWS OPERATOR TO CHANGE ORIENTATION FROM FOOT TO HEAD. THE FINAL IMAGE ON THE FILM WILL HAVE THE PATIENT LEFT AND RIGHT SIDES REVERSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOSHIBA X-SPEED COMPUTER TOMOGRAPHY SYSTEM JAK TOSHIBA MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 *