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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 Problem Material Protrusion/Extrusion (2979)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/13/2014
Event Type  malfunction  
Event Description
The customer reported that the system failed to boot to a usable state and exhibited a non-recoverable loss of functionality.No patient serious injury or death was reported related to this event.
 
Manufacturer Narrative
A ge service representative performed an onsite investigation.The system software and calibrations were evaluated and 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 (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 Key4324410
MDR Text Key14880823
Report Number1720753-2014-09573
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Reporter Country CodeTH
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 12/04/2014
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 Number9900
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/13/2014
Initial Date FDA Received12/04/2014
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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