BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVA 1.5T

    MDR report key: 1802429 · Received August 9, 2010

    Report

    Report Number
    3003768277-2010-00153
    Event Type
    Injury
    Date Received
    August 9, 2010
    Report Date
    July 29, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LNH
    PMA / PMN Number
    K063559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 PT HAD A MR PROCEDURE. THEY WERE SCANNED WITH THE SENSE BODY COIL. AFTER THE EXAMINATION A SECOND DEGREE BURN WITH A BLISTER SIZE OF APPROX 2 CM WAS FOUND ON THE UPPER RIGHT HIP. ALSO, A SECOND DEGREE BURN WITH A BLISTER SIZE OF APPROX 1 CM WAS ON THE PT'S WRIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACHIEVA 1.5T LNH (MAGNETIC RESONANCE DIAGNOSTIC DEVICE) LNH PHILIPS MEDICAL SYSTEMS 781296 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other