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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) ENTRAK 2500; RADIOLOGICAL IMAGE PROCESSING
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GE OEC MEDICAL SYSTEMS (SLC) ENTRAK 2500; RADIOLOGICAL IMAGE PROCESSING Back to Search Results
Model Number ENTRAK 2500
Device Problems Intermittent Continuity (1121); Computer Operating System Problem (2898)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/30/2015
Event Type  malfunction  
Event Description
The customer reported that the system intermittently failed to boot to a usable state and exhibited intermittent functionality.No pt serious injury or death was reported related to this event.
 
Manufacturer Narrative
A ge service representative performed an over the phone investigation.The keyboard was identified as a possible cause of the issue.No conclusion can be drawn as further system analysis or repair info is unavailable at this time and no additional service info was provided.
 
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Brand Name
ENTRAK 2500
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 Key4723579
MDR Text Key5582484
Report Number1720753-2015-01735
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 04/21/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberENTRAK 2500
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/30/2015
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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