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

Model Number 9800

Device Problem Device Remains Activated (1525)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 11/29/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reported multiple instances of brief unintended fluoroscopic x-ray exposures over multiple patient cases.A ge service representative performed an onsite investigation.The reported issue could not be duplicated.The footswitch x-ray controller was replaced during the service event.A supplemental report will be submitted at the conclusion of the investigation which was opened related to the events surrounding this complaint.

Event Description

The customer reported that fluoroscopic x-ray stays on after releasing the footswitch.This event may have resulted in an aro (accidental radiation occurrence).No patient death or serious injury was reported related to this event.

Manufacturer Narrative

A root cause investigation was completed related to the reported event.Analysis of the system log files surrounding the event did not provide any evidence of a stuck footswitch.The cause for the stuck switch is unknown, as the fe was unable to reproduce the issue and the returned footswitch could not be obtained for testing.A review of the service history determined that the footswitch was greater than thirteen years old and no replacement has been identified prior to (b)(6) 2016.No further actions are planned by the manufacturer at this time.

• Brand Name: 9800
• Type of Device: FLUOROSCOPIC X-RAY
• Manufacturer (Section D): GE OEC MEDICAL SYSTEMS (SLC); 384 wright brothers drive; salt lake city UT
• Manufacturer Contact: 384 wright brothers drive; salt lake city, UT
• MDR Report Key: 6181507
• MDR Text Key: 62627057
• Report Number: 1720753-2016-03446
• Device Sequence Number: 1
• Product Code: OWB
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9800
• Device Lot Number: 89-1958
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• 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