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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 Degraded (1153); No Display/Image (1183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/26/2014
Event Type  malfunction  
Event Description
The customer reported the fluoroscopic image was degraded effectively eliminating the ability to view a usable image.No pt death or serious injury was reported related to this event.
 
Manufacturer Narrative
A ge service rep performed an onsite investigation.The reported issue could not be duplicated.The monitor cables and workstation pcbs were evaluated and reseated.The system was tested and found to be working as intended and put back into 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 Key3860958
MDR Text Key4455871
Report Number1720753-2014-03201
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Reporter Country CodeAS
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 04/14/2014
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 Number8800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/26/2014
Initial Date FDA Received04/14/2014
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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