BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNA HDX

    MDR report key: 1727160 · Received May 24, 2010

    Report

    Report Number
    1727160
    Event Type
    Malfunction
    Date Received
    May 24, 2010
    Date of Event
    April 15, 2010
    Report Date
    May 21, 2010
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PRESSURE PLATE (RUPTURE DISC) LOCATED DIRECTLY ABOVE MRI UNIT HAD RELEASED HELIUM GAS INTO DEDICATED MRI DUCT SYSTEM LEADING TO THE ROOF. THE GAS ESCAPED OUT OF THE APPROPRIATE AREA.====================== HEALTH PROFESSIONAL'S IMPRESSION======================DURING CHECKS AND ANALYSIS, WE COULD NOT FIND A REASON OR CAUSE FOR THE "QUENCHING OF THE MAGNET." THESE THINGS HAPPEN SOMETIMES WITH REASON, SOMETIMES WITHOUT. THIS ONE WAS ONE THAT HAS NO REASON THAT WE CAN ASCERTAIN ACCORDING TO OUR ANALYSIS AND INVESTIGATING OF THE ERROR LOGS OF THE SYSTEM. THE SYSTEM IS RUNNING WELL. THIS SELDOM HAPPENS, BUT WE ARE CONTINUING TO DO OUR DAILY CHECKS TO KEEP TABS ON THE SYSTEM. THE RUPTURE DISC BURST, VENTING CRYOGENIC HELIUM INTO THE OUTDOOR ATMOSPHERE. WE ARE NOT SURE WHY IT BURST. THERE WAS NO PATIENT IN THE ROOM AT THE TIME AND, EXCEPT FOR SOME WATER VAPOR THAT DEVELOPED IN THE AREA SURROUNDING THE DISCHARGE DUCT (THAT LEADS TO THE ROOFTOP HOOD), THERE DID NOT SEEM TO BE ANY DISCHARGE INTO THE ROOM. THERE IS A SLIGHT SULFUR SMELL IN THE AIR THAT NO ONE CAN IDENTIFY. TWO CLINICAL ENGINEERING TECHNICIANS ARE LOOKING OVER THE MAGNET AND COMPUTER ROOM AND ASSURE US THAT THERE IS NO DANGER PRESENT TO ANYONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNA HDX MRI LNH GE MEDICAL SYSTEMS, LLC SIGNA HDX *

    Patients

    Seq Age Sex Outcome Treatment
    1 *