BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVA 1.5T NOVA DUAL

    MDR report key: 5761053 · Received June 30, 2016

    Report

    Report Number
    3003768277-2016-00062
    Event Type
    Injury
    Date Received
    June 30, 2016
    Date of Event
    May 27, 2016
    Report Date
    June 6, 2016
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    LNH
    PMA / PMN Number
    K052013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    SERVICE PERSONNEL

    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 INJURIES AT BOTH INNER THIGHS WERE CAUSED BY SKIN-TO-SKIN CONTACT. ONLY A SHEET WAS USED AS PADDING AND IT WAS STATED THAT THERE WAS POTENTIAL FOR SKIN-TO-SKIN CONTACT. FURTHERMORE THE FOLLOWING FACTORS WERE OBSERVED THAT CONTRIBUTED TO THE EVENT: THE PATIENT WAS OBESE WHICH MAY INDICATE A HAMPERED THERMO-REGULATION, THE PATIENT WAS COVERED BY SHEET , USED SCAN PROTOCOL; 4 SCANS WITH HIGH SAR VALUE AND A TOTAL WHOLE BODY RF DOSE OF 5.0 KJ/KG. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED A REPORT THAT A PATIENT EXPERIENCED A HEATING SENSATION AND REDDENING OF THE SKIN AND BLISTERS WITH A SIZE OF 3-4CM AT THE INNER THIGHS WERE OBSERVED. THE PATIENT WAS POSITIONED FEET FIRST SUPINE AND SCANNED FOR A PELVIS EXAMINATION WITH THE TORSO XL COIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418043 ACHIEVA 1.5T NOVA DUAL SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH PHILIPS HEALTHCARE 781173

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other