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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) 9900; FLUOROSCOPIC X-RAY
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GE OEC MEDICAL SYSTEMS (SLC) 9900; FLUOROSCOPIC X-RAY Back to Search Results
Model Number 9900
Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/06/2015
Event Type  malfunction  
Event Description
The customer reported a loss of vascular imaging mode functionality.No patient or user injury was reported related to this event.
 
Manufacturer Narrative
A ge service representative performed an on site investigation.The cine hard disk drive was evaluated and replaced.The system software and calibration were also reloaded.The system was tested and found to be working as intended and returned to service.
 
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Brand Name
9900
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 Key4948979
MDR Text Key6635930
Report Number1720753-2015-03017
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 07/27/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9900
Device Lot NumberE2-1976
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/06/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2011
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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