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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY NUCLEAR MAGNETIC RESONANCE IMAGING

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GE MEDICAL SYSTEMS, LLC SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problems Break (1069); Fire (1245); Smoking (1585); Arcing (2583)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/12/2019
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. Unique identifier: udi not required. 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 an exam was completed, an mr technologist entered the magnet room and noticed a smell of smoke. The technologist removed the patient from the room and re-entered to see the glow of a flame underneath the rear covers of the mr system. The technologist used a non-ferrous extinguisher to put out the flame. The initial investigation found the heating occurred in an area of pinched and damaged cables under the scanner bridge. The patient was unaware of the issue, and no injury occurred.
 
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Brand NameSIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY
Type of DeviceNUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
GE MEDICAL SYSTEMS, LLC
3200 n grandview blvd.
waukesha, WI 53188
Manufacturer Contact
jacqui budde
3200 n. grandview blvd.
waukesha, WI 
MDR Report Key8776168
MDR Text Key150688705
Report Number2183553-2019-00013
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2019
Is this an Adverse Event Report? No
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 Received08/08/2019
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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