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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS 8800; FLUOROSCOPIC X-RAY
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GE OEC MEDICAL SYSTEMS 8800; FLUOROSCOPIC X-RAY Back to Search Results
Model Number 8800
Device Problems Failure to Back-Up (1047); No Display/Image (1183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/20/2015
Event Type  malfunction  
Event Description
The customer reported that the system failed to properly save and recall patient image data.No patient serious injury or death was reported related to this event.
 
Manufacturer Narrative
A ge service representative performed an onsite investigation.The hard disk drive was evaluated and replaced.The system software and calibrations were also reloaded.The system was tested and found to be working as intended and returned to service.
 
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Brand Name
8800
Type of Device
FLUOROSCOPIC 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 Key4524112
MDR Text Key5538427
Report Number1720753-2015-00665
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Reporter Country CodeUS
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 02/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/20/2015
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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