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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE (TIANJIN) COMPANY LIMITED SIGNA EXPLORER NUCLEAR MAGNETIC RESONANCE IMAGING

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GE HEALTHCARE (TIANJIN) COMPANY LIMITED SIGNA EXPLORER NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problems Fire (1245); Device Emits Odor (1425); Overheating of Device (1437)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 01/22/2018
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. (b)(4). 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 after a patient was removed from the mr suite following a scan, the technologist noticed a burning smell in the scan room. A ge field service engineer (fse) was on site and investigated. The power to the scanner was removed. Flames were noticed in the back of the room and put out with a non-magnetic fire extinguisher. No patient or healthcare person was involved and no injury occurred.
 
Manufacturer Narrative
Ge healthcare's internal investigation concluded the most probable cause of the event was a high voltage cable, damaged during installation, exposing bare conductors. Located under the floor in a trough of cabling, it is speculated these conductors arced during normal use while also being immersed in an atypical leaking conductive fluid. This event has been shown to be an isolated incident. No systemic failure was identified. The mr system has been repaired, tested, and turned back over to the customer.
 
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Brand NameSIGNA EXPLORER
Type of DeviceNUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
GE HEALTHCARE (TIANJIN) COMPANY LIMITED
no.266 jingsan road
tianjin airport economic area
tianjin
CH
Manufacturer Contact
jacqui budde
3200 n. grandview blvd.
waukesha, WI 
MDR Report Key7284570
MDR Text Key100594091
Report Number3010949642-2018-00001
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143251
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/20/2018
Is this a Product Problem Report? Yes
Device Operator
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 Received04/12/2018
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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