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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 Stops Intermittently (1599); Loss of Data (2903)
Patient Problem No Patient Involvement (2645)
Event Date 01/23/2017
Event Type  malfunction  
Manufacturer Narrative
A ge service representative performed an onsite investigation.The interconnect cable was evaluated and ordered for replacement.No conclusion can be drawn as further system analysis, testing or repair information is unavailable at this time and no additional service information was provided.
 
Event Description
The customer reported that the system froze and failed to save patient images.No patient serious injury or death was reported related to 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 Key6341654
MDR Text Key67807127
Report Number1720753-2017-00512
Device Sequence Number1
Product Code OWB
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Type of Report Initial
Report Date 02/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2017
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
Was the Report Sent to FDA? No
Date Manufacturer Received01/23/2017
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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