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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) ENTRAK RADIOLOGICAL IMAGE PROCESSING

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GE OEC MEDICAL SYSTEMS (SLC) ENTRAK RADIOLOGICAL IMAGE PROCESSING Back to Search Results
Model Number ENTRAK
Device Problem Device Inoperable
Event Date 10/11/2016
Event Type  Malfunction  
Manufacturer Narrative

A ge service representative performed an onsite investigation. The hard disk drive and motherboard were evaluated and replaced. The system was tested and found to be working as intended and returned to service.

 
Event Description

The customer reported that the system failed to boot up. No patient serious injury or death was reported related to this event.

 
Manufacturer Narrative

The investigation into the reported event determined that there was no device malfunction. This is not a reportable event. Complaint investigation: the fse confirmed the problem reported by the customer of system will not boot. The fse determined the cause of the problem to be faulty hard drive with bad sectors. The fse verified system functionality. The partitioned serial ata hard-drive that contains operating systems, and also contains the system software. The hard drive holds software that is a set of instructions that directs the system processor to perform specific operations. A bad sector is a sector on a computer's disk drive or flash memory that is either inaccessible or unwriteable due to permanent damage, such as physical damage to the disk surface or failed flash memory transistors. Replaced other components as part of the troubleshooting and repair. Based on age of the system, manufactured before 2006, this type of failure would be expected and reflective of the normal wear and tear that is anticipated as the system is used. This complaint does not represent a malfunction.

 
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Brand NameENTRAK
Type of DeviceRADIOLOGICAL IMAGE PROCESSING
Manufacturer (Section D)
GE OEC MEDICAL SYSTEMS (SLC)
384 wright brothers drive
salt lake city UT 84116
Manufacturer (Section G)
GE OEC MEDICAL SYSTEMS (SLC)
384 wright brothers drive
salt lake city UT 84116
Manufacturer Contact
384 wright brothers drive
salt lake city , UT 84116
MDR Report Key6080527
Report Number1720753-2016-03019
Device Sequence Number1
Product CodeLLZ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 02/01/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/04/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberENTRAK
Device LOT NumberIT25241G
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/10/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/1970
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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