BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITAN

    MDR report key: 7009341 · Received November 8, 2017

    Report

    Report Number
    7009341
    Event Type
    Malfunction
    Date Received
    November 8, 2017
    Date of Event
    August 28, 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

    WHEN CHECKED INTO WORK THIS MORNING, ERROR ON MONITOR FOR MRI SYSTEM STATED HELIUM WARNING, BELOW 30%. I OPENED UP SCAN ROOM DOOR, TESTED MAGNET TO SEE IF THERE WAS A MAGNETIC FIELD, AND THERE WAS NOT. SERVICE WAS IMMEDIATELY CALLED, AND SERVICE ENGINEER CAME IN. HE STATED HE BELIEVED IT WAS AN "UNATTENDED QUENCH". SERVICE ENGINEER STATED WE WILL BE DOWN FOR 5 DAYS. MORE THAN 50 PATIENTS ARE AFFECTED BY THE SYSTEM BEING DOWN. ALL PATIENTS FOR ENTIRE WEEK HAVE TO BE CANCELLED/RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787893 TITAN SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH TOSHIBA MEDICAL SYSTEMS CORPORATION MKSU-ECGU04

    Patients

    Seq Age Sex Outcome Treatment
    1