Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS ENTRAK 2500; RADIOLOGICAL IMAGE PROCESSING
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GE OEC MEDICAL SYSTEMS ENTRAK 2500; RADIOLOGICAL IMAGE PROCESSING Back to Search Results
Model Number ENTRAK 2500
Device Problems Mechanical Problem (1384); Loss of Power (1475); Device Stops Intermittently (1599)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/04/2014
Event Type  malfunction  
Event Description
The customer reported that the system was intermittently shutting down or locking-up.There is no report of death or serious injury associated with the complaint.
 
Manufacturer Narrative
A ge service representative performed an onsite investigation.The tracker flash card was evaluated and replaced.The system was tested and found to be working as intended and returned to service.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ENTRAK 2500
Type of Device
RADIOLOGICAL IMAGE PROCESSING
Manufacturer (Section D)
GE OEC MEDICAL SYSTEMS
384 wright brothers dr.
salt lake city UT 84116
Manufacturer (Section G)
GE OEC MEDICAL SYSTEMS
384 wright brothers dr.
salt lake city UT 84116
Manufacturer Contact
384 wright brothers dr.
salt lake city, UT 84116
8015364952
MDR Report Key4380101
MDR Text Key20780017
Report Number1720753-2014-09944
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 12/26/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2014
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 Received12/04/2014
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
-
-