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U.S. Department of Health and Human Services

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

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GE OEC MEDICAL SYSTEMS (SLC) ENTRAK PLUS RADIOLOGICAL IMAGE PROCESSING Back to Search Results
Model Number ENTRAK PLUS
Device Problem Device Stops Intermittently (1599)
Patient Problem No Patient Involvement (2645)
Event Date 07/01/2016
Event Type  malfunction  
Manufacturer Narrative
A ge service representative performed an onsite investigation. The system bios (software) was evaluated and reset. The system was tested and found to be working as intended and returned to service.
 
Event Description
The customer reported that the system locked up. No patient serious injury or death was reported related to this event.
 
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Brand NameENTRAK PLUS
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 Key5817479
MDR Text Key50292540
Report Number1720753-2016-01885
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/22/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberENTRAK PLUS
Device Lot NumberIT25191P
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/01/2016
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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