BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIA ELITION X

    MDR report key: 9888799 · Received March 27, 2020

    Report

    Report Number
    MW5093952
    Event Type
    Injury
    Date Received
    March 27, 2020
    Date of Event
    February 5, 2020
    Report Date
    March 26, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B. V.
    Product Code
    LNH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    BG
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    MRI BURNOUT; ON FEBRUARY 5TH, THE MRI SCANNER SUPPLIED BY PHILIPS HEALTHCARE / MEDICAL SYSTEMS, (B)(4) HAS BURNT. THE FIRE / SMOKE STARTED FROM MAGNET. THERE WAS A SMOKE DURING PATIENT SCAN AND SCAN WAS STOPPED AND ASKED PHILIPS ENGINEER TO VISIT TO CHECK THE PROBLEM. DURING ENGINEER TESTING THE PHANTOM SCANS SMOKE EMITTED FROM MAGNET AND COMPLETE MRI WAS BURNT. FORTUNATELY, THERE WAS NOT PT DURING THIS TIME. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351819 INGENIA ELITION X SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH PHILIPS MEDICAL SYSTEMS NEDERLAND B. V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O| R