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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC NUCLEAR MAGNETIC RESONANCE IMAGING DISCOVERY MR450

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GE MEDICAL SYSTEMS, LLC NUCLEAR MAGNETIC RESONANCE IMAGING DISCOVERY MR450 Back to Search Results
Device Problems Thermal Decomposition of Device (1071); Arcing (2583)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 12/11/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information not provided as there was no adverse event. (b)(4). 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 a ge healthcare field engineer found a burn mark on the inner wall of the mr scanner bore. The customer had attempted to scan a patient, but the system would not scan. The patient was removed and rescheduled, with no injury to the patient. The burn mark, which wasn't noticed until examination by the field engineer, was in an area that would normally be accessible to the patient during a scan.
 
Manufacturer Narrative
Ge healthcare (gehc) investigation has been completed. The body coil was visually inspected, tuning was checked, and the coil was evaluated at gehc. The primary root cause of the mr 450 body coil issue was due to electrical arcing. The arcing occurred because of high electric fields in the application, insufficient distance between conductive parts and contamination on the board. In this condition, arcing occurs across the board surface. No injury occurred, and the rf body coil was replaced via an action in the field.
 
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Brand NameNUCLEAR MAGNETIC RESONANCE IMAGING
Type of DeviceDISCOVERY MR450
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 Key8231981
MDR Text Key132573697
Report Number2183553-2019-00001
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K083147
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 04/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/09/2019
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 Received03/08/2019
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
Removal/Correction Number2183553-02/01/17-001-C

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