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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC SIGNA 3.0T MR750 SYSTEM NUCLEAR MAGNETIC RESONANCE IMAGING

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GE MEDICAL SYSTEMS, LLC SIGNA 3.0T MR750 SYSTEM NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problems Fire (1245); Overheating of Device (1437); Smoking (1585); Arcing (2583)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 06/13/2017
Event Type  malfunction  
Manufacturer Narrative
There is no additional patient information. There are no additional device identification numbers. Ge healthcare's investigation is ongoing. A follow up report will be submitted once the investigation has been completed. Device evaluation anticipated, but not yet begun.
 
Event Description
It was reported that while scanning a patient, the mr scanner stopped. The technologist went into the mr scan room and smelled and noticed smoke. The patient was removed from the room. The technologist then noticed an orange glow coming from a gap between the doors of the magnet room closet. It was determined that the gradient cables were arcing in the closet causing a small flame. The fire alarm was pulled. The technologist put out the flame with an extinguisher before the fire department arrived. No injuries were reported. The ge field engineer replaced all gradient cables and the filter panel assembly. The system passed all gradient diagnostic tests, system performance tests and test scans. The system was turned back over to the customer for use. Received sus voluntary event report #mw5070499.
 
Manufacturer Narrative
The investigation by ge healthcare has been completed. Based upon the analysis, installation workmanship is the singular root cause of this incident. The lack of proper mechanical retention due to improper crimping, coupled with a reduced cross-sectional area caused by cut strands, prevented a hermetic seal from being formed. The resistivity of the cable connections continued to increase over 5 years to the point where enough voltage potential was created to allow an electrical arc to form. The small flame that occurred at the gradient filter box was contained to only the plastic safety cover and damage was isolated to the enclosed area of the penetration panel. Toxicology of the burnt acrylic plastic electrical safety cover and fire-retardant pvc gradient cable insulation material indicate that no toxic chemicals were released during the time of combustion. This incident has been assessed as a minor hazard. If this event were to recur, it is not likely to lead to a serious injury.
 
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Brand NameSIGNA 3.0T MR750 SYSTEM
Type of DeviceNUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
GE MEDICAL SYSTEMS, LLC
3200 n grandview blvd.
waukesha WI
Manufacturer Contact
jacqui budde
3200 n. grandview blvd.
waukesha, WI 
MDR Report Key6712469
MDR Text Key80137745
Report Number2183553-2017-00012
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Radiologic Technologist
Type of Report Initial,Followup
Report Date 10/12/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/13/2017
Is this a Product Problem Report? Yes
Device Operator
Other Device ID NumberUDI_NOT_REQUIRED
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/1970
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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