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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 Loss of Data (2903)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/09/2015
Event Type  malfunction  
Event Description
The customer reported that the system failed to properly save and recall pt image data.No pt serious injury or death was reported related to this event.
 
Manufacturer Narrative
A ge service rep performed an on site investigation.The single board computer (sbc) was evaluated and upgraded along with all required pcb's and the hard disk drive.The system was tested and 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 Contact
384 wright brothers dr.
salt lake city, UT 84116
8015364952
MDR Report Key4942195
MDR Text Key6633795
Report Number1720753-2015-02964
Device Sequence Number1
Product Code JAA
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 Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/23/2015
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
Device Lot Number82-1576
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/29/2015
Initial Date FDA Received07/23/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2002
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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