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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) INSTATRAK 3500; RADIOLOGICAL IMAGE PROCESSING
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GE OEC MEDICAL SYSTEMS (SLC) INSTATRAK 3500; RADIOLOGICAL IMAGE PROCESSING Back to Search Results
Model Number INSTATRAK 3500
Device Problems Device Stops Intermittently (1599); Computer Operating System Problem (2898)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/06/2014
Event Type  malfunction  
Event Description
The customer reported that the system intermittently failed to boot to a usable state and exhibited intermittent functionality.No patient serious injury or death was reported related to this event.
 
Manufacturer Narrative
A ge service representative performed a remote investigation.The system was evaluated and the user was asked to reboot the system.System functionality was restored and the system was returned to service.
 
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Brand Name
INSTATRAK 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 Key3791986
MDR Text Key4384413
Report Number1720753-2014-00502
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 01/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberINSTATRAK 3500
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/06/2014
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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