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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); Loss of Power (1475); Arcing (2583); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/24/2014
Event Type  malfunction  
Event Description
The customer reported the system made a loud click noise and thereafter the image blackened.Following a reboot it remained functional for a short time, but then repeated characteristics or arcing and shut down.There is no report of death or serious injury.
 
Manufacturer Narrative
A ge service rep performed an on site investigation.The x-ray tube, tube cover and high voltage cable were 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 (SLC)
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 Key4173351
MDR Text Key5102192
Report Number1720753-2014-06815
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 08/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2014
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
Date Manufacturer Received07/24/2014
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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