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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) 9800; FLUOROSCOPIC X-RAY
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GE OEC MEDICAL SYSTEMS (SLC) 9800; FLUOROSCOPIC X-RAY Back to Search Results
Model Number 9800
Device Problems No Display/Image (1183); Arcing (2583)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/14/2014
Event Type  malfunction  
Event Description
It was reported that the system was arching, which caused the live image to go black.This resulted in a temporary loss of imaging functionality.Functionality was recovered with a reboot.There is no report of injury or death associated with this event.
 
Manufacturer Narrative
A ge service representative performed an onsite investigation.The failure could not be duplicated.The candle sticks were evaluated and regreased.A complete filament calibration was performed.The system was tested and found to be working as intended and put back into service.
 
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Brand Name
9800
Type of Device
FLUOROSCOPIC X-RAY
Manufacturer (Section D)
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 Key4142921
MDR Text Key17158462
Report Number1720753-2014-07875
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 09/12/2014
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 09/08/2014
Initial Date FDA Received09/12/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2002
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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