BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERA 1.5T

    MDR report key: 4908343 · Received July 13, 2015

    Report

    Report Number
    3003768277-2015-00056
    Event Type
    Injury
    Date Received
    July 13, 2015
    Date of Event
    August 7, 2014
    Report Date
    June 19, 2015
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    LNH
    PMA / PMN Number
    K001987
    Removal / Correction Number
    NUMBER NOT PROVIDED YET.
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE PROVIDED INFORMATION AND TESTS PERFORMED ON SITE THERE IS NO INDICATION OF A MALFUNCTION OF THE MR SYSTEM. IT IS CONCLUDED THAT THE INJURY OF THE PATIENT IS CAUSED BY NOT KEEPING SUFFICIENT DISTANCE BETWEEN THE COIL CABLE AND PATIENT SKIN. A COTTON TOWEL WAS USED AS PADDING BETWEEN THE COIL CABLES AND THE PATIENT SKIN BUT THIS DOES NOT ENSURE SUFFICIENT DISTANCE (2CM). AS CONTRIBUTING FACTORS WERE IDENTIFIED: 6 SCANS ON HIGH SAR. A TOTAL DELIVERED WHOLE BODY RF DOSE OF 4.7 KJ/KG. THE PATIENT WAS OBESE. FOR THE SYNERGY BODY COIL IT IS KNOWN THAT THE POSITIONING OF THE COIL CABLES CAN CREATE UNINTENDED RESONANCES VIA THE PATIENT OR ELEVATED COIL CABLE TEMPERATURE DUE TO RF COUPLING TO THE QBC. HOWEVER WHEN THE INSTRUCTIONS FOR USE IS FOLLOWED NO SERIOUS INJURY IS EXPECTED. CORRECTION: PATIENT AGE AND WEIGHT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO PHILIPS THAT A PATIENT SUSTAINED A 4 CM BLISTER ON THE HIP AFTER AN MRI EXAMINATION WITH AN INTERA 1.5T MR. THE PATIENT WAS POSITIONED HEAD FIRST SUPINE AND SCANNED WITH THE SYNERGY BODY COIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453195 INTERA 1.5T SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH PHILIPS HEALTHCARE 781195

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other