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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC OPTIMA MR450W NUCLEAR MAGNETIC RESONANCE IMAGING

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GE MEDICAL SYSTEMS, LLC OPTIMA MR450W NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problems Fire (1245); Smoking (1585); Device Misassembled During Manufacturing /Shipping (2912)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 10/11/2018
Event Type  malfunction  
Manufacturer Narrative
Unique identifier: (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 to ge healthcare that the customer was in between scans, prepping the patient, when the technologist noticed smoke and a flame at the back of the scanner. The technologist pressed the emergency off, the examination was stopped, and the patient was removed from the scanner. The technologist then used an extinguisher to put out the flame. The ge field engineer was called and initial investigation found that the y gradient lead had arced leading to localized damage. No injury occurred.
 
Manufacturer Narrative
The investigation by ge healthcare (gehc) has been completed and concluded that the "y-" gradient lug was broken and loose from the terminal. The investigation concluded there were no witness (b)(6) on the "y-" lug mating surfaces or nut to indicate correct tightness. This is a unique situation potentially caused by interruptions on the build process leading to incorrect tightening of this gradient connection. This event has been shown to be an isolated incident. The customer site has been corrected and the system has been turned back over for clinical use.
 
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Brand NameOPTIMA MR450W
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 Key8034854
MDR Text Key126173824
Report Number2183553-2018-00015
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K123522
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/02/2018
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 Received03/17/2019
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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