BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X08A

    MDR report key: 7013633 · Received November 9, 2017

    Report

    Report Number
    7013633
    Event Type
    Malfunction
    Date Received
    November 9, 2017
    Date of Event
    July 11, 2017
    Report Date
    September 29, 2017
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS CORPORATION
    Product Code
    LNH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MRI SCANNER SCREEN WAS FROZEN WHILE SCANNING A PATIENT. MRI TECHNOLOGIST HAD TO SHUT SCANNER DOWN NUMEROUS TIMES DURING AM SHIFT. MRI DEPT GOT 2+ HRS BEHIND SCHEDULE, ENGINEER WAS NOTIFIED AND TOLD US TO SHUT SCANNER DOWN FOR 30 MINUTES. TWO PATIENTS WERE RE-SCHEDULED FOR A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791782 X08A SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH TOSHIBA MEDICAL SYSTEMS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1