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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 Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Arcing (2583)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/06/2014
Event Type  malfunction  
Event Description
The fe reported that the system was arcing, causing the system to lock up.There is no report of death or serious injury.
 
Manufacturer Narrative
A ge service rep performed an on site investigation.The hv terminals were evaluated and cleaned.The x-ray tube was reworked.The system was tested, found to be working as intended and returned to 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 dr.
salt lake city UT 84116
Manufacturer (Section G)
GE OEC MEDICAL SYSTEMS (SLC)
384 wright brothers dr.
salt lake city UT 84116
Manufacturer Contact
384 wright brothers dr.
salt lake city, UT 84116
8015364952
MDR Report Key4286033
MDR Text Key5230781
Report Number1720753-2014-09227
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2014
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
Date Manufacturer Received10/31/2014
Was Device Evaluated by Manufacturer? Yes
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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