MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) ENTRAK 2500; RADIOLOGICAL IMAGE PROCESSING

Model Number ENTRAK 2500

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 10/14/2015

Event Type  malfunction  

Manufacturer Narrative

A ge service representative performed an onsite investigation.The ultra 10 cpu was 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 and exhibited a non-recoverable loss of system functionality.No patient serious injury or death was reported related to this event.

• Brand Name: ENTRAK 2500
• Type of Device: RADIOLOGICAL 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 Key: 5206236
• MDR Text Key: 30570158
• Report Number: 1720753-2015-04474
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENTRAK 2500
• Device Lot Number: IT25040
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1