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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) ITRAK 3500; RADIOLOGICAL IMAGE PROCESSING
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GE OEC MEDICAL SYSTEMS (SLC) ITRAK 3500; RADIOLOGICAL IMAGE PROCESSING Back to Search Results
Model Number ITRAK 3500
Device Problems Device Inoperable (1663); Computer Operating System Problem (2898)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/04/2014
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 computer was evaluated and replaced.The calibration files were reloaded.The system was tested and found to be working as intended and returned to service.
 
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Brand Name
ITRAK 3500
Type of Device
RADIOLOGICAL IMAGE PROCESSING
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 Key3823284
MDR Text Key16600084
Report Number1720753-2014-02516
Device Sequence Number1
Product Code LLZ
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 03/20/2014
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 NumberITRAK 3500
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/04/2014
Initial Date FDA Received03/20/2014
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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