BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACHIEVA 1.5T NOVA

    MDR report key: 2401061 · Received January 4, 2012

    Report

    Report Number
    3003768277-2011-00570
    Event Type
    Death
    Date Received
    January 4, 2012
    Date of Event
    November 25, 2011
    Report Date
    December 6, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    LNH
    PMA / PMN Number
    K052013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    AN INTENSIVE CARE PT WHO WAS ALSO SEDATED WAS SCANNED ON A MR SYSTEM. AFTER THE SCAN, THE TREATING DOCTOR DIAGNOSED THE DEATH OF THE PT AS THE RESULT OF A HEART ATTACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACHIEVA 1.5T NOVA LNH PHILIPS HEALTHCARE 781196

    Patients

    Seq Age Sex Outcome Treatment
    1 Death