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 08/09/2016

Event Type  malfunction  

Manufacturer Narrative

A ge service representative performed an onsite investigation.The reported issue could not be duplicated.The customer reported unintended fluoroscopic x-ray exposure to the patient witnessed by the live image monitor updating.The fse reseated connectors on the power supply, on the back plane and on the signal interface board.The system was evaluated and returned to service.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 mainframe exposure switch.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 determined that there was no conclusive evidence of an un-commanded x-ray event.No device malfunction was identified and no repair of the device was conducted in relation to the event.Subsequently, no root cause could be identified and 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 84116
• Manufacturer (Section G): GE OEC MEDICAL SYSTEMS (SLC); 384 wright brothers drive; salt lake city UT 84116
• Manufacturer Contact: 384 wright brothers drive; salt lake city, UT 84116
• MDR Report Key: 5926836
• MDR Text Key: 53895023
• Report Number: 1720753-2016-02381
• 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: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2016
• 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: 82-3762
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2016
• 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