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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HANGWEI MEDICAL SYSTEMS CO., LTD. GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM NUCLEAR MAGNETIC RESONANCE IMAGING

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GE HANGWEI MEDICAL SYSTEMS CO., LTD. GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problems Image Orientation Incorrect (1305); Connection Problem (2900); Misassembled During Installation (4049)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. Incident date is not known. There are no additional device identification numbers. Unique identifier udi_not_required. 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 laterality (right and left) of the mr images was incorrect. Ge healthcare (gehc) service identified that during prior system servicing/troubleshooting, the gradient cables of the x axis had been swapped and not returned to their correct positions. Gehc service placed the gradient cables to their correct positions. No injury or misdiagnosis was reported due to this issue.
 
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Brand NameGE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
Type of DeviceNUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
GE HANGWEI MEDICAL SYSTEMS CO., LTD.
west area of building no.3
no.1 yongchang north road
beijing 10017 6
CH 100176
Manufacturer Contact
jacqui budde
3200 n. grandview blvd.
waukesha, WI 
MDR Report Key9172682
MDR Text Key207945869
Report Number9613445-2019-00007
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K053009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/09/2019
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? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/09/2019
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

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