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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) 9900; FLUOROSCOPIC X-RAY
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GE OEC MEDICAL SYSTEMS (SLC) 9900; FLUOROSCOPIC X-RAY Back to Search Results
Model Number 9900
Device Problem Device Remains Activated (1525)
Patient Problem No Patient Involvement (2645)
Event Date 12/06/2016
Event Type  malfunction  
Manufacturer Narrative
A ge service representative performed an onsite investigation.The mainframe exposure switch was evaluated and replaced.The system was tested and found to be working as intended and returned to service.
 
Event Description
The customer reported that x-ray continued to be emitted after release of the mainframe switch.There is no report of patient involvement, a patient injury or death associated with this event.
 
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Brand Name
9900
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 Key6251714
MDR Text Key64893639
Report Number1720753-2017-00187
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 01/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number9900
Device Lot NumberE9-0578
Other Device ID NumberNOT APPLICABLE
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/21/2016
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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