BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 1.5T

    MDR report key: 3190178 · Received June 18, 2013

    Report

    Report Number
    3003768277-2013-00029
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Report Date
    June 7, 2013
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    LNH
    PMA / PMN Number
    K001987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (EVAL METHOD, RESULTS, CONCLUSIONS): - THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A F/U REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A FIRE BEHIND THE COVERS OF THE MR SYSTEM. THE PT WAS EVACUATED AND THE FIRE WAS EXTINGUISHED. NOBODY WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275973 INTERA 1.5T LNH PHILIPS HEALTHCARE 781195

    Patients

    Seq Age Sex Outcome Treatment
    1