BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA EXCITE 1.5T

    MDR report key: 1812347 · Received August 16, 2010

    Report

    Report Number
    2183553-2010-00034
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 31, 2010
    Report Date
    August 2, 2010
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K041476
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PULSE SEQUENCES USED FOR THE EXAM WERE FSE, GRE, EPI, ASSET, EPI AND FLAIR. THE DURATIONS FOR THE SERIES WERE THE FOLLOWING: LOC (9SEC), LOC (9SEC), ASSET (12SEC), VASC PC (29SEC), VASC PC (29SEC), EPI (2.16SEC), FLAIR (2.20SEC), AX T2 (47SEC), GRE (1.48SEC), AX T1 (1.43SEC), COR T2 (47SEC), VASC PC (1.06SEC), SPGR (4.32SEC), 3D TOF (5.51SEC), 3D TOF- (12.50SEC), AX T2 (2.49SEC), COR FLAIR (2.20SEC), LOC (9SEC), VASC PC (27SEC), ANGIO GD (1.44SEC), SPGR 3D (2.43SEC), AND AX T1 (2.27SEC). GE HEALTHCARE HAS INITIATED AN INVESTIGATION FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANESTHETIZED PATIENT SUSTAINED A 10-CM BURN ON THE POSTERIOR ASPECT OF THE UPPER RIGHT ARM DURING A MRI BRAIN EXAM. THE BURN AREA DEVELOPED MULTIPLE 1-CM BLISTERS. ADDITIONAL SMALLER BLISTERS WERE OBSERVED. THERE WAS NO INFORMATION ON MEDICAL TREATMENT RECEIVED BY THE PATIENT. THE EXAM CONSISTED OF 22 SCANS THAT LASTED 1 HOUR AND 21 MINUTES. THE EXAM UTILIZED AN 8-CHANNEL INVIVO NEUROVASCULAR ARRAY. THE CUSTOMER STATED THAT RECOMMENDED MR PADDING WAS NOT APPLIED ON THE PATIENT BECAUSE THE PATIENT WAS NOT TOUCHING THE BORE. INSTEAD, THE CUSTOMER USED TOWELS AND BLANKETS TO BE PLACED AROUND THE PATIENT. THE BURN WAS NOT NOTICED UNTIL THE PATIENT WOKE UP AFTER THE EXAM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other INVIVO NEUROVASCULAR ARRAY