MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS ENTRAK 2500; RADIOLAOGICAL IMAGE PROCESSING

Model Number ENTRAK 2500

Device Problems Mechanical Problem (1384); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2015

Event Type  malfunction  

Event Description

It was reported the system displayed a field distortion message and locked up.There is no report of death or serious injury associated w/the complaint.

Manufacturer Narrative

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

• Brand Name: ENTRAK 2500
• Type of Device: RADIOLAOGICAL 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: 4652305
• MDR Text Key: 5754569
• Report Number: 1720753-2015-01352
• 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: 03/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2015
• 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
• Date Manufacturer Received: 03/11/2015
• 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