BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVA 1.5T NOVA

    MDR report key: 1802424 · Received August 9, 2010

    Report

    Report Number
    3003768277-2010-00151
    Event Type
    Injury
    Date Received
    August 9, 2010
    Date of Event
    July 11, 2010
    Report Date
    July 29, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LNH
    PMA / PMN Number
    K052013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THE PATIENT HAD A MR EXAM. SHE WAS SCANNED IN THE HEAD FIRST SUPINE POSITION WITH THE FOUR CHANNEL SHOULDER COIL. HER RIGHT ARM WAS AT HER SIDE. WITHIN 48 HOURS AFTER THE EXAMINATION A LARGE 2ND TO 3RD DEGREE BURN WAS FOUND ON HER INNER FOREARM NEAR THE ELBOW. THE INTERFACE BOX WAS DIRECTLY IN CONTACT WITH THE PT'S ARM DURING THE EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACHIEVA 1.5T NOVA LNH (MAGNETIC RESONANCE DIAGNOSTIC DEVICE) LNH PHILIPS MEDICAL SYSTEMS 781196 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other