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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC DISCOVERY MR750W 3.0T NUCLEAR MAGNETIC RESONANCE IMAGING

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GE MEDICAL SYSTEMS, LLC DISCOVERY MR750W 3.0T NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/12/2018
Event Type  malfunction  
Manufacturer Narrative
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 the customer was scanning a patient. The scan was stopped to reposition the patient. The customer then noticed a burning smell. The examination was stopped and the patient was removed from the scanner. No injury occurred. The customer stopped using the scanner and called their field engineer (fe). The fe found that the rf body coil had a burn mark.
 
Manufacturer Narrative
Ge healthcare's investigation has determined that a small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used. A cable mode rf condition present in the design of the 750w rf body coil is the most probable root cause of the arcing that leads to excessive heat/discoloration on the surface of the patient bore. Ge healthcare is initiating an action in the field as reported to the fda under correction number 2183553-06/13/18-002-c on june 13, 2018.
 
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Brand NameDISCOVERY MR750W 3.0T
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 Key7298913
MDR Text Key101243378
Report Number2183553-2018-00004
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130115
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 06/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/27/2018
Is this an Adverse Event Report? No
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 Received05/23/2018
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
Removal/Correction Number2183553-06/13/18-002-C

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