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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) 9900; FLUOROSCOPIC X-RAY
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GE OEC MEDICAL SYSTEMS (SLC) 9900; FLUOROSCOPIC X-RAY Back to Search Results
Model Number 9900
Device Problem Failure to Back-Up (1047)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/09/2015
Event Type  malfunction  
Event Description
The customer reported the system showed errors when saving the images.The fe reported the system did not save images.There is no report of death or serious injury.
 
Manufacturer Narrative
A ge service representative performed an investigation.The reported issue could not be duplicated.Onsite investigation revealed that no cause could be determined.The system was tested and found to be working as intended and put back into service.
 
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Brand Name
9900
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 Key4534556
MDR Text Key21563504
Report Number1720753-2015-00728
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Reporter Country CodeBR
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 02/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9900
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/11/2015
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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