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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) 6800; FLUOROSCOPIC X-RAY
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GE OEC MEDICAL SYSTEMS (SLC) 6800; FLUOROSCOPIC X-RAY Back to Search Results
Model Number 6800
Device Problems Failure to Back-Up (1047); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/13/2015
Event Type  malfunction  
Event Description
It is reported that when attempting to save the images the error message high current was displayed and images could not be saved.There was no patient injury or death reported.
 
Manufacturer Narrative
A ge service representative performed an on site investigation.The reported issue could not be duplicated.The system was tested and found to be working as intended and put back into service.
 
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Brand Name
6800
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 Key4652243
MDR Text Key5754548
Report Number1720753-2015-01363
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Reporter Country CodeGM
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 03/31/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number6800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/13/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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