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 Known Impact Or Consequence To Patient (2692)

Event Date 07/29/2014

Event Type  malfunction  

Manufacturer Narrative

A ge service representative performed an onsite investigation and determined that the cpu required replacement.No conclusion can be drawn as conclusive repair information is unavailable at this time and no additional information was provided.

Event Description

The customer reported that the system failed to boot to a usable state and exhibited a non-recoverable loss of 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 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 ; 8015364952
• MDR Report Key: 4041312
• MDR Text Key: 19045403
• Report Number: 1720753-2014-07115
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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: 08/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENTRAK 2500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2014
• Initial Date FDA Received: 08/19/2014
• 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 Number: 1