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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 Device Remains Activated (1525); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 11/16/2016
Event Type  malfunction  
Manufacturer Narrative
A ge service representative performed an onsite investigation.Multiple system pcb and ic chipset assembly connections were evaluated and reseated.The mainframe x-ray exposure switch was also replaced as part of the service event.The system was tested and found to be working as intended and returned to service.
 
Event Description
The customer reported that x-ray was emitted when the user initiated the vertical lift switch.There was no patient involvement.There is no report of a patient injury or death associated with this event.
 
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Brand Name
9800
Type of Device
FLUOROSCOPIC X-RAY
Manufacturer (Section D)
GE OEC MEDICAL SYSTEMS (SLC)
384 wright brothers drive
salt lake city UT
Manufacturer Contact
384 wright brothers drive
salt lake city, UT 
MDR Report Key6156866
MDR Text Key61857995
Report Number1720753-2016-03347
Device Sequence Number1
Product Code OWB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Type of Report Initial
Report Date 12/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number9800
Device Lot Number89-0289
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/16/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/1970
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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