BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIA 1.5T

    MDR report key: 4435780 · Received January 19, 2015

    Report

    Report Number
    3003768277-2015-00006
    Event Type
    Injury
    Date Received
    January 19, 2015
    Date of Event
    December 30, 2014
    Report Date
    December 30, 2014
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    LNH
    PMA / PMN Number
    K110151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE PROVIDED INFORMATION AND TEST PERFORMED ON SITE THERE IS NO INDICATION OF A MALFUNCTION OF MR SYSTEM OR COIL. IT CONCLUDED THAT THIS HEATING INCIDENT IS A SKIN TO SKIN HEATING INCIDENT CAUSED BY RF CURRENT LOOP FORMATION INSIDE THE LEFT ARM PIT OF THE PATIENT. NO PADDING WAS USED BETWEEN THE ARMS AND SIDE OF THE PATIENT TO PREVENT SKIN-SKIN CONTACT. IN THIS CASE SEVERAL FACTORS WERE OBSERVED THAT CONTRIBUTED TO THE SUSTAINED INJURY: THE PATIENT WAS OBESE AND COVERED BY A COTTON SHEET; 4 SCANS ON HIGH SAR VALUE WERE CONDUCTED AND THE TOTAL DELIVERED SPECIFIC ENERGY DOSE (SED) WAS 3726 J/KG.

    Description of Event or Problem · 1

    PHILIPS RECEIVED A REPORT FROM A CUSTOMER THAT A PATIENT SUSTAINED REDDENING OF THE SKIN (2 INC IN DIAMETER) AND 2 BLISTERS OF 3/4 INCH IN THE LEFT ARM PIT AFTER AN MRI EXAMINATION. THE PATIENT WAS POSITIONED HEAD FIRST SUPINE AND SCANNED WITH THE DS NVC COIL FOR A CERVICAL SPINE EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43120 INGENIA 1.5T SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH PHILIPS HEALTHCARE 781396

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other