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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 Problem Failure to Power Up (1476)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 07/09/2015
Event Type  malfunction  
Event Description
The customer reported that the system had a kv on in error at boot up, the screen went black, and the system had to be reboot.There was no patient injury or death reported.
 
Manufacturer Narrative
A ge service representative performed an on site investigation.The backplane was replaced during the service call.The system was tested and found to be working as intended and put back into service.
 
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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 84116
Manufacturer (Section G)
GE OEC MEDICAL SYSTEMS (SLC)
384 wright brothers drive
salt lake city UT 84116
Manufacturer Contact
384 wright brothers drive
salt lake city, UT 84116
MDR Report Key4950610
MDR Text Key6191522
Report Number1720753-2015-03061
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Health Professional
Type of Report Initial
Report Date 07/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9800
Device Lot Number82-1005
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/09/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2001
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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