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

Model Number ITRAK 3500

Device Problem Failure to Power Up (1476)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 04/16/2015

Event Type  malfunction  

Event Description

It was reported that the system locked up.There was no pt injury or death reported.

Manufacturer Narrative

A ge service rep 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: ITRAK 3500
• Type of Device: RADIOLOGICAL IMAGE PROCESSING
• Manufacturer (Section D): 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 Key: 4739781
• MDR Text Key: 5703593
• Report Number: 1720753-2015-01830
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ITRAK 3500
• Device Lot Number: IT35222P
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2015
• 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