BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVA 1.5T NEW

    MDR report key: 3111167 · Received May 8, 2013

    Report

    Report Number
    3003768277-2013-00023
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 18, 2013
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    LNH
    PMA / PMN Number
    K063559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): METHOD - THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO FDA. RESULTS - THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA. CONCLUSIONS - THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT WAS SCANNED WITH THE NVC COIL AND SENSE SPINE COIL ON AN ACHIEVA 1.5T SYSTEM. AFTER THE EXAMINATION SECOND DEGREE BURNS WERE OBSERVED ON THE LEFT THUMB (APPROX. 0.7 CM) AND THE LEFT THIGH (APPROX. 2 CM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202214 ACHIEVA 1.5T NEW LNH PHILIPS HEALTHCARE 781296

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other