BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVA 1.5T NOVA

    MDR report key: 1912387 · Received November 16, 2010

    Report

    Report Number
    3003768277-2010-00309
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 19, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LNH
    PMA / PMN Number
    K052013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS SCANNED IN THE HEAD FIRST POSITION WITH THE SENSE HEAD COIL. THE CABLES WERE BESIDES THE RIGHT ARM OF THE PATIENT; NO PROTECTIVE MEASURES WERE TAKEN TO SEPARATE THE CABLE FROM THE PATIENT'S ARM. AFTER THE EXAM, A SECOND DEGREE BURN WITH A SIZE OF APPROX 1X3 WAS FOUND ON THE RIGHT ARM, BETWEEN THE HAND AND THE ELBOW. INVESTIGATION IS ONGOING, FURTHER DETAILS WILL FOLLOW.

    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 55 YR Other