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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) 8800; FLUOROSCOPIC X-RAY
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GE OEC MEDICAL SYSTEMS (SLC) 8800; FLUOROSCOPIC X-RAY Back to Search Results
Model Number 8800
Device Problems Loss of Data (2903); Mechanics Altered (2984)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/22/2014
Event Type  malfunction  
Event Description
The customer reported that the system locked up.There is no report of death or serious injury associated with the complaint.This resulted in a loss of imaging functionality.
 
Manufacturer Narrative
A ge service representative performed an on site investigation.The x-ray tube was evaluated and replaced.A complete filament calibration and beam alignment was performed.The system was tested and found to be working as intended and returned to service.
 
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Brand Name
8800
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 Key4176574
MDR Text Key5094471
Report Number1720753-2014-08579
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 10/13/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/22/2014
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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