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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS 9900; FLUOROSCOPIC X-RAY
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GE OEC MEDICAL SYSTEMS 9900; FLUOROSCOPIC X-RAY Back to Search Results
Model Number 9900
Device Problems Failure to Back-Up (1047); Computer Operating System Problem (2898)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/14/2015
Event Type  malfunction  
Event Description
It was reported that the system would not save images and later would not boot up.There was no patient injury or death reported.
 
Manufacturer Narrative
A ge service representative performed an on site investigation.The connectors were reseated and the power connector was repaired during the service call.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
384 wright brothers dr.
salt lake city UT 84116
Manufacturer (Section G)
GE OEC MEDICAL SYSTEMS
384 wright brothers dr.
salt lake city UT 84116
Manufacturer Contact
384 wright brothers dr.
salt lake city, UT 84116
8015364952
MDR Report Key4482534
MDR Text Key5497821
Report Number1720753-2015-00424
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/30/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2015
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 Received01/14/2015
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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