BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIA 1.5T

    MDR report key: 5427250 · Received February 10, 2016

    Report

    Report Number
    3003768277-2016-00016
    Event Type
    Injury
    Date Received
    February 10, 2016
    Date of Event
    January 20, 2016
    Report Date
    January 21, 2016
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    LNH
    PMA / PMN Number
    K110151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 OR COIL USED. IT IS CONCLUDED THAT THE INJURY ON THE LEFT LOWER BACK IS CAUSED BY THE CLOSE PROXIMITY OF THE BODY TO THE BORE WALL. NO PADDING WAS USED BETWEEN THE PATIENT AND THE BORE WALL AND IT WAS STATED THAT THE PATIENT WAS IN DIRECT CONTACT WITH THE BORE WALL CLOSE TO THE AFFECTED AREA. FURTHER CONTRIBUTING FACTORS IDENTIFIED WERE: -TOTAL SPECIFIC ENERGY DOSE (SED) OF 4.0KJ/KG. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED A REPORT THAT A PATIENT EXPERIENCED A HEATING SENSATION AND A BLISTER OF 4 CM WAS OBSERVED ON THE OUTSIDE OF THE LEFT LOWER BACK. THE PATIENT WAS POSITIONED FEET FIRST SUPINE, OBLIQUE, OFF CENTER AND SCANNED FOR A RIGHT WRIST MR EXAMINATION USING THE SENSE SMALL EXTREMITY 8 COIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84620 INGENIA 1.5T SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH PHILIPS HEALTHCARE 781341

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other