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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC SIGNA ARTIST NUCLEAR MAGNETIC RESONANCE IMAGING

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GE MEDICAL SYSTEMS, LLC SIGNA ARTIST NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problems Installation-Related Problem (2965); Unintended Movement (3026)
Patient Problem No Patient Involvement (2645)
Event Date 05/18/2018
Event Type  malfunction  
Manufacturer Narrative
(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 servicing a newly replaced magnet, the helium in the magnet vessel expelled into the customer¿s unfinished quench vent releasing helium into the customer¿s equipment room. Servicing was performed prior to customer turn over, not during customer use. No injuries occurred as a result of this incident. At this time, it is conservatively believed that if this malfunction were to recur, it would be likely to result in a serious injury.
 
Manufacturer Narrative
Ge healthcares (gehc) investigation has been completed. It was found that service was being performed on a de-energized magnet during site construction and installation of the mr system. The gehc field engineer (fe) was working on the helium coldhead and was following the appropriate process and safety measures associated with this type of service. During the service, there was a release of helium, which is inherently unique to magnets. Since the magnet was not ramped up, no quench occurred. There was no malfunction and no injury occurred.
 
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Brand NameSIGNA ARTIST
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 Key7705764
MDR Text Key114803435
Report Number2183553-2018-00009
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K163331
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 08/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
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 Received08/10/2018
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 Initial

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