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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS 9800; FLUROSCOPY X-RAY
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GE OEC MEDICAL SYSTEMS 9800; FLUROSCOPY X-RAY Back to Search Results
Model Number 9800
Device Problems Device Stops Intermittently (1599); Loss of Data (2903)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/02/2014
Event Type  malfunction  
Event Description
The customer reported that the system intermittently would not display a live fluoroscopy image, thus making the system unusable due to a loss of imaging functionality.There is no report of injury or death associated with the event described in this complaint.
 
Manufacturer Narrative
No conclusion can be drawn as conclusive repair information is unavailable at this time and no additional service information was provided.
 
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Brand Name
9800
Type of Device
FLUROSCOPY X-RAY
Manufacturer (Section D)
GE OEC MEDICAL SYSTEMS
384 wright brothers dr.
salt lake city UT 84116
Manufacturer (Section G)
GE OEC MEDICAL SYSTEMS
384 wright brothers dr.
salt lake city UT 84116
Manufacturer Contact
384 wright brothers dr.
salt lake city, UT 84116
8015364952
MDR Report Key4207263
MDR Text Key4978189
Report Number1720753-2014-08837
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 10/22/2014
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 10/02/2014
Initial Date FDA Received10/22/2014
Was Device Evaluated by Manufacturer? No
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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