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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) 9800; FLUOROSCOPIC X-RAY
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GE OEC MEDICAL SYSTEMS (SLC) 9800; FLUOROSCOPIC X-RAY Back to Search Results
Model Number 9800
Device Problem Failure to Align (2522)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/24/2014
Event Type  malfunction  
Event Description
The customer reported that patient identification data and image data did not align.There is no report of death or serious injury.
 
Manufacturer Narrative
A ge service representative performed an on site investigation.The system software was evaluated and reloaded.The generator and workstation back up configuration were restored.The system was tested and found to be working as intended and returned to service.
 
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Brand Name
9800
Type of Device
FLUOROSCOPIC X-RAY
Manufacturer (Section D)
GE OEC MEDICAL SYSTEMS (SLC)
384 wright brothers dr.
salt lake city UT 84116
Manufacturer (Section G)
GE OEC MEDICAL SYSTEMS (SLC)
384 wright brothers dr.
salt lake city UT 84116
Manufacturer Contact
384 wright brothers dr.
salt lake city, UT 84116
8015364952
MDR Report Key4321599
MDR Text Key5206794
Report Number1720753-2014-09559
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Reporter Country CodeTW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 12/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/24/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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