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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 Consequences Or Impact To Patient (2199)
Event Date 05/22/2014
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 over the phone investigation.The customer was advised that the computer fru had to be replaced.The customer decided to call back later.No conclusion can be drawn at this time.
 
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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 (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 Key3963029
MDR Text Key4624538
Report Number1720753-2014-04908
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 06/11/2014
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 05/22/2014
Initial Date FDA Received06/11/2014
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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