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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 Device Stops Intermittently (1599); Mechanics Altered (2984)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/06/2015
Event Type  malfunction  
Event Description
The customer reported that the system intermittently locked up.There is no report of injury or death associated with the event described in this complaint.
 
Manufacturer Narrative
A ge service rep performed an on site investigation.The reported issue could not be duplicated.The system was rebooted during the service call.The system was tested and found to be working as intended and put back into service.
 
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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
8014364952
MDR Report Key4706515
MDR Text Key18259885
Report Number1720753-2015-01645
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 04/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2015
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 Received04/06/2015
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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