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 09/23/2016

Event Type  malfunction  

Manufacturer Narrative

A ge service representative performed an onsite investigation.The customer reported additional brief unintended fluoroscopic x-ray exposure to the patient.The customer's reported issue could not be duplicated.The generator interface (gib) pcb was evaluated and replaced.The associated calibrations were also reloaded as part of the service event.The system was tested, found to be working as intended 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 system was exposing on it's own resulting in a brief unintended exposure to a patient.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 this event.Analysis of the system log files surrounding the time of the incident, as well as other information related to the event determined that there was no evidence of x-ray having been generated without command or lasting longer than intended on the date reported by the user ((b)(6) 2016).There is no evidence of an accidental radiation occurrence (aro) related to this event.

• 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: 6084218
• MDR Text Key: 59332438
• Report Number: 1720753-2016-03043
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2016
• 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