BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGNA HDX 1.5T

    MDR report key: 1648230 · Received March 31, 2010

    Report

    Report Number
    2183553-2010-00007
    Event Type
    Death
    Date Received
    March 31, 2010
    Date of Event
    March 3, 2010
    Report Date
    March 4, 2010
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    GE CONDUCTED AN ON-SITE INVESTIGATION AND OBTAINED THE FOLLOWING INFORMATION: THE POSITION OF THE FE AS SHE WAS DISCOVERED, THE SIZE OF THE MR ROOM WAS OBSERVED TO BE SMALL, AND THE ROOM WAS USED FOR STORAGE. PHOTOGRAPHS WERE TAKEN OF THE ROOM SETUP. IN ADDITION, THE INVESTIGATION TEAM FOUND THAT SPARE PARTS AND TOOLS WERE FOUND AT THE OPERATOR CONSOLE, INDICATING EVIDENCE THAT A SERVICE ON THE BLOWER MOTOR WAS BEING PERFORMED. THERE WAS NO EVIDENCE THAT A MR SYSTEM MALFUNCTION CAUSED OR CONTRIBUTED TO THE EVENT. THE ROOM SIZE WAS REPORTEDLY SMALL; HOWEVER, FURTHER REVIEW OF THE ROOM SCHEMATICS SHOWED THAT THE ROOM MET INSTALLATION REQUIREMENTS. A REVIEW OF THE PHOTOGRAPHS OF THE ROOM'S SETUP DEMONSTRATED THAT THE ROOM WAS USED FOR STORAGE. FOR EXAMPLE, THE PHOTOGRAPHS SHOWED THAT PHANTOMS WERE LOCATED ON THE FLOOR AND THE PHANTOM CART WAS STATIONED INSIDE THE ROOM. ADDITIONALLY, THE SCREEN ROOM, ESPECIALLY AT AND BEHIND THE MAGNET, APPEARED TO BE CLUTTERED WITH SEVERAL ITEMS. IT WAS ALSO NOTED THAT THE SERVICE PATH ALONG THE LEFT SIDE OF THE MAGNET WAS OBSTRUCTED. THERE WAS NO WITNESS TO HOW THE EVENT TRANSPIRED EXACTLY. HOWEVER, BASED ON THE INFORMATION GATHERED BY THE INVESTIGATION TEAM, THE FOLLOWING SCENARIO WAS PROBABLE: THE FE WAS AT THE CUSTOMER SITE TO SERVICE THE PATIENT BLOWER. THE FE FOLLOWED PROPER INSTRUCTIONS TO SERVICE THE BLOWER. ONCE THE BLOWER PANEL WAS REMOVED, SHE FOLLOWED PROCEDURES TO KEEP THE MAGNETIC PART OF THE PANEL AWAY FROM THE MAGNET. HOWEVER, DUE TO THE SIZE OF THE ROOM AND THE CLUTTER PRESENT AT THAT TIME, THE FE HAD TO POSITION HERSELF BETWEEN THE PANEL AND THE MAGNET. THE PART WEIGHED APPROXIMATELY 30 POUNDS, WHICH MAY SUGGESTS THAT SHE WAS CARRYING THE PANEL WITH BOTH HANDS WITH HER BACK TO THE MAGNET AS SHE PROCEEDED TO WALK OUT OF THE ROOM. THE PHANTOM CART, NOTED ABOVE, WAS POSITIONED SUCH THAT THE FE HAD TO MANEUVER AROUND THE CART. DURING THIS MANEUVER, SOMETHING OCCURRED THAT CAUSED THE FE TO POSITION HERSELF CLOSER TO THE MAGNET THAT CONSEQUENTLY LED THE PANEL AND THE FE TO BE PULLED TOWARD THE MAGNET. IT IS UNKNOWN WHAT OCCURRED THAT AFFECTED THE FE'S PROXIMITY TO THE MAGNET. THE PANEL, HOWEVER, WOULD HAVE HAD SIGNIFICANT FORCE TO INCAPACITATE AND TRAP THE FE AS IT REACHED THE MAGNET. THIS WAS CONSISTENT WITH THE CAUSE OF DEATH AS REPORTED BY THE MOROCCAN EXAMINER. BASED ON THE INVESTIGATION, THE PROBABLE CAUSE OF THE EVENT WAS A COMBINATION OF THE SMALL ROOM CONTAINING OBSTRUCTIONS DURING THE SERVICE ACTIVITY, AND MAGNETIC MATERIALS FALLING IN CLOSE PROXIMITY TO THE MAGNET.

    Description of Event or Problem · 1

    A FATALITY INVOLVING A THIRD PARTY FIELD ENGINEER (FE) WAS REPORTED TO GE HEALTHCARE ON MARCH 4, 2010 BY THE DISTRIBUTOR. THE SEQUENCE OF EVENTS WERE AS FOLLOWS: THE FE WAS CALLED DIRECTLY BY THE CUSTOMER SITE TO SERVICE THE MR SYSTEM'S PATIENT BLOWER MOTOR DUE TO NOISE. THE FE ARRIVED AND CHECKED IN AT THE SITE AT 2100 HOURS. AT 2300 HOURS, A NIGHT GUARD CHECKED IN ON THE FE AND OBTAINED NO RESPONSE; THE GUARD DID NOT INVESTIGATE FURTHER. ACCOUNTS FROM THE SITE INDICATED THAT THE FE WAS FOUND DECEASED THE FOLLOWING MORNING AT APPROXIMATELY 0800 HOURS BY A SITE PERSONNEL. GE SERVICE PERSONNEL VISITED THE SITE ON MARCH 5, 2010 TO INVESTIGATE THE INCIDENT. ACCORDING TO THE INFORMATION THEY RECEIVED, THE FE WAS FOUND STANDING AT THE RIGHT BACKSIDE OF THE MAGNET WITH HER RIGHT ARM AND HEAD IN THE BORE, WHILE HER LEFT ARM WAS TOWARD THE REAR PEDESTAL. THE BLOWER PLATE, CONSISTING OF BLOWER AND MOTORS, WAS ATTACHED TO HER LEFT NECK AND HEAD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Death