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

Model Number INSTATRAK 3500

Device Problems Device Stops Intermittently (1599); Computer Operating System Problem (2898)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2014

Event Type  malfunction  

Event Description

It was reported that the system would not boot up.The system was shut down, allowed to sit, then it would boot up.This caused an intermittent total loss of navigation functionality.There is no report of injury or death associated with the event described in this complaint.

Manufacturer Narrative

A ge service representative performed an on site investigation.The reported issue could not be duplicated.The system was tested and found to be working as intended and put back into service.

• Brand Name: INSTATRAK 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: 4366057
• MDR Text Key: 5287303
• Report Number: 1720753-2014-09892
• 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: 12/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INSTATRAK 3500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2014
• 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