BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA 1.5 ECHO

    MDR report key: 2210555 · Received August 10, 2011

    Report

    Report Number
    2183553-2011-00032
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 13, 2011
    Report Date
    August 10, 2011
    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
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN MRI OF THE HIPS USING THE 12 CHANNEL TORSO COIL FOLLOWED BY AN MRI OF THE SHOULDER. THE PATIENT WAS SEDATED FOR THE EXAM. THE PATIENT WAS MONITORED WITH EKG/BLOOD PRESSURE CUFF AND PULSE OXIMETER. THE PULSE OXIMETER WAS ON THE LEFT INDEX FINGER. THE SITE DID USE PADS ALONG WITH DRAW SHEET, AND PAD BENEATH THE PATIENT USED FOR TRANSPORTING. BETWEEN EXAMS NO INJURY WAS OBSERVED. FOR THE SHOULDER EXAM THE PATIENT DID HAVE THE CABLES ON TOP OF HIM RUNNING OUT OF THE BORE. AFTER THE EXAM THE NURSE NOTED THE POSTERIOR SIDE OF THE LEFT FOREARM WAS RED AND A LARGE BLISTER (SIZE OF A DOLLAR BILL) WAS SEEN. THE RADIOLOGIST ASSESSED THE BURN AND CALLED THE PRIMARY PHYSICIAN TO REPORT THE INJURY. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNA 1.5 ECHO MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other