BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVA 1.5T NOVA

    MDR report key: 2831132 · Received November 6, 2012

    Report

    Report Number
    3003768277-2012-00081
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 21, 2012
    Report Date
    October 21, 2012
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    LNH
    PMA / PMN Number
    K052013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (CONCLUSIONS) - THE INCIDENT REPORTED WAS CAUSED BY THE CLOTHING WORN BY THE PT. THE PT WAS NOT CHANGED IN HOSPITAL CLOTHING AND THE STRESS WORN BY THE PT CONTAINED EMBROIDERY WITH CONDUCTING MATERIAL. THE BURNS OCCURRED ON THE ABDOMEN PART CORRESPONDING TO THE LOCATION OF THE EMBROIDERY. THE INSTRUCTIONS FOR USE CONTAIN WARNING RELATED TO THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A FEMALE PT WAS EXAMINED WITH A COMBINATION OF THE 15 CHANNEL SPINE AND 16 CHANNEL NEURO VASCULAR (NV) COIL. THERE WAS NOTHING ABNORMAL OBSERVED DURING THE EXAMINATION. THE PT WENT HOME AND INFORMED THE HOSPITAL AFTER OF A BURN, A SECOND DEGREE BURN OF 4X4 CAM WAS OBSERVED ON THE ABDOMEN AND CHEST.

    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 60 YR Other