BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTERAL 1.5T POWER/PULSAR

    MDR report key: 1746463 · Received June 28, 2010

    Report

    Report Number
    3003768277-2010-00111
    Event Type
    Other
    Date Received
    June 28, 2010
    Date of Event
    June 17, 2010
    Report Date
    June 17, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    LNH
    PMA / PMN Number
    K001796
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE COIL WAS CHECKED ON SITE AND THE INFO PROVIDED BY FIELD REP WAS REVIEWED BY COMPLAINT HANDLING TEAM OF MFR. CONCLUSIONS: (USER ERROR CONTRIBUTED TO EVENT). I WAS STATED IN THE BURN QUESTIONNAIRE THAT INITIALLY, SUFFICIENT DISTANCE WAS APPLIED BETWEEN COIL CABLE AND PT. BUT, THAT THERE IS A POSSIBILITY THAT THE PT MOVED HIS HAND, RESULTING IN AN INSUFFICIENT DISTANCE (<2CM). NO PADDING WAS USED. ALSO, HIGH SAR VALUES MAY HAVE CONTRIBUTED TO THE BURN. OVERALL, IT IS MOST LIKELY THAT THIS BURN WAS CAUSED BY UNWANTED RF INTERFERENCE BEING FACILITATED BY THE INSUFFICIENT DISTANCE BETWEEN COILED CABLE AND THE PT'S HAND. ALTHOUGH NO VISIBLE DAMAGE WAS OBSERVED ON THE OUTSIDE, THE INTERNAL SHIELDING OF THE COIL MAY HAVE BEEN DAMAGED BY MECHANICAL WEAR. DEPENDING ON THE POSITION OF THE COIL AND THE PT, THIS CAN LEAD TO HEATING OF THE COIL CABLE OR ELEMENTS AND/OR UNWANTED RF INTERFERENCE. THE COIL WILL BE REPLACED ON SITE.

    Description of Event or Problem · 1

    PT HAD A MR EXAM. HE WAS SCANNED WITH THE SENSE BODY COIL WITH IT POSITIONED IN THE ABDOMEN AREA. AFTER THE EXAMINATION, A SECOND DEGREE BURN WITH A BLISTER 1.5 CM WAS OBSERVED ON THE DORSAL PART OF THE LEFT HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERAL 1.5T POWER/PULSAR LNH (MAGNETIC RESONANCE DIAGNOSTIC DEVICE) LNH PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 781105 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other