MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) ITRAK 3500; RADIOLOGICAL IMAGE PROCESSING

Model Number ITRAK 3500

Device Problems Device Inoperable (1663); Computer Operating System Problem (2898)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2014

Event Type  malfunction  

Event Description

The customer reported that the system would not boot up.This resulted in a total loss of navigation functionality.This could result in the delay or cancellation of a procedure.There is no report of injury or death associated with this event.

Manufacturer Narrative

The customer canceled the service call.

• Brand Name: ITRAK 3500
• 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: 4047605
• MDR Text Key: 4906064
• Report Number: 1720753-2014-07220
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ITRAK 3500
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/13/2014
• Was Device Evaluated by Manufacturer?: No
• 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