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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 Disconnection (1171); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/31/2015
Event Type  malfunction  
Event Description
The customer reported a loss of vascular imaging mode functionality.No patient user or user injury was reported related to this event.
 
Manufacturer Narrative
A ge service representative performed an onsite investigation.The cine hard disk drive cables and connections were evaluated, cleaned and reseated.The system was tested and found to be working as intended and returned to 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 Key4718030
MDR Text Key5739721
Report Number1720753-2015-01730
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 04/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 03/31/2015
Initial Date FDA Received04/20/2015
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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