BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS HEALTHCARE SCANNING SYSTEM

    MDR report key: 8189698 · Received December 20, 2018

    Report

    Report Number
    MW5082403
    Event Type
    Injury
    Date Received
    December 20, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS MR FINLAND
    Product Code
    LNH
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A VETERAN PT WAS ALLOWED TO ENTER THE BORE UNWANDED FOR METAL. THIS PERSON HAD A KNIFE WITH IRON OR NICKEL CONTENT IN THEIR POCKET. THE KNIFE WAS ATTRACTED TO THE STATIC MAGNETIC FIELD IN THE BORE OF THE SCANNER, AND FLEW OUT OF THE POCKET IMPACTING THE BORE. THIS ITEM'S IMPACT CAUSED PAIN TO THE PT AND PHYSICAL DENT IN THE BORE OF THE MRI SCANNER. THIS PHILIPS MRI ((B)(4)) IS OWNED AND OPERATED BY CONTRACT ((B)(4)) BETWEEN HEALTHCARE PROVIDER IS HEALTHCARE ((B)(6)) AND THE US FEDERAL GOVERNMENT (B)(6). DATES OF USE: (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027543 PHILIPS HEALTHCARE SCANNING SYSTEM SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH PHILIPS MEDICAL SYSTEMS MR FINLAND INGENIA AMBITION 1.5T

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R