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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC SIGNA HDX 1.5T

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GE MEDICAL SYSTEMS, LLC SIGNA HDX 1.5T Back to Search Results
Model Number 2395001
Event Date 03/03/2010
Event Type  Death  
Event Description

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.

 
Manufacturer Narrative

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.

 
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Brand NameSIGNA HDX 1.5T
Manufacturer (Section D)
GE MEDICAL SYSTEMS, LLC
3200 n. grandview blvd.
waukesha WI 53158
Manufacturer (Section G)
GE MEDICAL SYSTEMS, LLC
3200 n. grandview blvd.
waukesha WI 53188
Manufacturer Contact
martha kamrow
3000 n. grandview blvd.
waukesha , WI 53188
2623127196
MDR Report Key1648230
Report Number2183553-2010-00007
Device Sequence Number1
Product CodeLNH
Report Source Manufacturer
Source Type Distributor
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 03/04/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/31/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Other
Device MODEL Number2395001
OTHER Device ID NumberSYS ID MA1152MR01
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Date Manufacturer Received03/04/2010
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/2008
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 03/31/2010 Patient Sequence Number: 1
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