BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE 1.5T SIGNA HDX MR SYSTEM

    MDR report key: 1946879 · Received December 28, 2010

    Report

    Report Number
    2183553-2010-00056
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    November 26, 2010
    Report Date
    December 28, 2010
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT HAD A CERVICAL AND LUMBAR MR EXAM (HNS COIL AND CTL ARRAY) UNDER ANESTHESIA. LATER A BURN WAS REPORTEDLY NOTICED ON THE PT'S RIGHT ELBOW THAT WAS DESCRIBED AS A 4 CM PARTIAL THICKNESS ERYTHEMATOUS (RED) PATCH WITH A BLISTER IN THE CENTER AND A POSSIBLE EXIT SITE. ATTEMPTS WERE MADE TO GET MORE DETAILS ABOUT THE SIZE OF THE BLISTER, HOWEVER THAT INFO COULD NOT BE OBTAINED. THE PT WAS REPORTEDLY POSITIONED HEADFIRST, SUPINE WITH ARMS AT THE SIDE. PADS OF 3/8-INCH THICKNESS WERE USED DURING THE SCAN. A TOTAL OF 24 SCANS WERE PERFORMED ON THE PT. THE PROCEDURE LASTED A TOTAL OF 2 HRS. THE PT WAS EXAMINED IN THE EMERGENCY DEPT WHERE X-RAYS WERE TAKEN AND PAIN MEDICATION PRESCRIBED. THE PT WAS ADVISED TO F/U WITH HIS PRIMARY CARE PHYSICIAN. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A F/U REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other