BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA HDX 1.5T

    MDR report key: 1334525 · Received March 4, 2009

    Report

    Report Number
    2183553-2009-00011
    Event Type
    Injury
    Date Received
    March 4, 2009
    Date of Event
    January 28, 2008
    Report Date
    February 4, 2009
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A PATIENT REPORTEDLY SUSTAINED SECOND DEGREE BURNS ON HER RIGHT ARM AFTER A MR EXAM. THE PATIENT WAS UNDERGOING A PELVIC SCAN USING THE BODY ARRAY COIL. AFTER THE EXAM, THE PATIENT COMPLAINED THAT HER ARM FELT HOT BUT DECLINED ANY TREATMENT. A FEW DAYS LATER, THE CUSTOMER RETURNED TO THE SITE WITH SECOND DEGREE BURNS ON HER ARM. THE GE FIELD ENGINEER (FE) HAS REPORTED THAT THE PATIENT'S ARMS WERE ON HER BREAST DURING THE EXAM. THE FE ALSO HAS INFORMED US THAT THE CUSTOMER DID NOT PAD THE PATIENT TO PREVENT SKIN CONTACT. THE PULSE SEQUENCE AND DURATIONS USED DURING THE EXAM WERE AS FOLLOWS: LOC-15SEC., FGR-13SEC., FRFSE-XL-4:27MIN., FSE-XL-2:59MIN., FRFSE-XL-2:43MIN., FRFSE-XL-5:11MIN., FRFSE-XL-4:25MIN., FRFSE-XL-5:23MIN., FRFSE-XL-4:44MIN., FRFSE-XL-5:09MIN., SAR VALUES ARE: SAR 0.2; PEAK SAR .5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNA HDX 1.5T LNH GE MEDICAL SYSTEMS, LLC 2395001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other