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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 Unstable (1667); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/29/2014
Event Type  malfunction  
Event Description
The customer reported that both of the monitors were not working properly.They are black at start up and then turn "snowy".This issue would prevent the live image from being viewed, thereby making the system unusable.There was no patient injury or death reported.
 
Manufacturer Narrative
A ge service representative performed an on site investigation.The hard drive was installed during the service call.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 (SLC)
384 wright brothers dr.
salt lake city UT 84116
Manufacturer Contact
384 wright brothers dr.
salt lake city, UT 84116
8015364952
MDR Report Key4189735
MDR Text Key5159050
Report Number1720753-2014-08730
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Reporter Country CodeNL
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 10/17/2014
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 09/29/2014
Initial Date FDA Received10/17/2014
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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