MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) 6800; FLUOROSCOPIC X-RAY

Model Number 6800

Device Problems Degraded (1153); Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2014

Event Type  malfunction  

Event Description

It was reported the fluoroscopic image was degraded effectively eliminating the ability to view a usable image.No pt serious injury or death was reported related to this event.

Manufacturer Narrative

A ge service rep performed an onsite investigation.The image processor board, sbc board and hard disk drive were evaluated and replaced.The system was tested and found to be working as intended and returned to service.

• Brand Name: 6800
• Type of Device: FLUOROSCOPIC X-RAY
• 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: 4043638
• MDR Text Key: 4861883
• Report Number: 1720753-2014-07161
• Device Sequence Number: 1
• Product Code: JAA
• 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: 6800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2014
• Initial Date FDA Received: 08/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2004
• 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