MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) 9900; FLUOROSCOPIC X-RAY

Model Number 9900

Device Problem Radiation Overexposure (3017)

Patient Problems No Known Impact Or Consequence To Patient (2692); Radiation Exposure, Unintended (3164)

Event Date 04/15/2015

Event Type  malfunction  

Event Description

The customer reported that unintended x-ray was produced when the user initiated the vertical lift of the system.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 ge service representative performed an onsite investigation.The reported issue could not be duplicated.The fse identified a potential short fluoroscopic exposure (2 seconds) of a patient, but actual exposure was unable to be confirmed.The fse tested the vertical lift column, but could not reproduce the issue.The system log files were analyzed and indicated that the system foot switch was activated triggering the unintended exposure.The generator interface pcb was evaluated and replaced as part of the service event.The system was tested and found to be working as intended and put back into service.This event may have resulted in an accidental radiation occurrence.

Manufacturer Narrative

A root cause investigation was conducted.An analysis of the log files surrounding the time of the event determined that the exposures were initiated by the pressing of an x-ray on switch and terminated normally.There is no evidence of an un-commanded x-ray event related to a system malfunction in conjunction with this complaint.

• Brand Name: 9900
• Type of Device: FLUOROSCOPIC X-RAY
• Manufacturer (Section D): 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: 4730090
• MDR Text Key: 5580202
• Report Number: 1720753-2015-01807
• Device Sequence Number: 1
• Product Code: JAA
• 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: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/23/2015

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: 9900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2015
• Initial Date FDA Received: 04/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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