MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) 9800; FLUOROSCOPIC X-RAY

Model Number 9800

Device Problems Device Displays Incorrect Message (2591); Radiation Overexposure (3017)

Patient Problem Radiation Overdose (1510)

Event Date 03/11/2014

Event Type  malfunction  

Event Description

The customer reported that the system exhibited filament regulator failure errors during a pt procedure.This event may have resulted in an aro (accidental radiation occurrence).No pt death or serious injury was reported related to this event.

Manufacturer Narrative

A ge service representative performed an onsite investigation.A full filament calibration was performed.The system was tested and found to be working as intended and returned to service.This malfunction may have resulted in a possible accidental radiation occurrence.

• Brand Name: 9800
• 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: 3835071
• MDR Text Key: 19085621
• Report Number: 1720753-2014-02810
• 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: 03/31/2014

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: 9800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2014
• Initial Date FDA Received: 03/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2002
• 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