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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS 9800; FLUOROSCOPIC X-RAY
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GE OEC MEDICAL SYSTEMS 9800; FLUOROSCOPIC X-RAY Back to Search Results
Model Number 9800
Device Problems Degraded (1153); Poor Quality Image (1408)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/20/2014
Event Type  malfunction  
Event Description
The customer reported the fluoroscopic image was degraded with halo effects when the system was moved to a lateral position effectively eliminating the ability to view a usable image.No patient death or serious injury was reported related to this event.
 
Manufacturer Narrative
A ge service representative performed an onsite investigation.The high voltage cable was evaluated and replaced.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
384 wright brothers dr.
salt lake city UT 84116
Manufacturer Contact
384 wright brothers dr.
salt lake city, UT 84116
8015364952
MDR Report Key3874577
MDR Text Key15363548
Report Number1720753-2014-03532
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 04/22/2014,04/02/2014
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 Number9800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/14/2014
Initial Date FDA Received04/22/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2005
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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