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

Model Number 9900

Device Problem Failure to Shut Off (2939)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 06/25/2015

Event Type  malfunction  

Event Description

It is reported that during an exam the system continued to expose a few seconds after the foot pedal was released.There was no patient injury or death reported.

Manufacturer Narrative

A ge service representative performed an onsite investigation.The foot switch was replaced during the service call.The system was tested adn found to be working as intended and put back into service.This malfunction resulted in an accidental radiation occurrence.

Manufacturer Narrative

Root cause investigation was conducted related to the reported issue.A review of the system log files identified an instance on (b)(4) 2015 on a single shot where the footswitch may have remained activated for an extended period (six seconds) which resulted in the x-rays being delivered for longer than the user intended.The foot switch was not available for component analysis.The foot switch was removed and replaced.The investigation concluded that the switch was designed and manufactured to meet necessary safety and operational requirements.The foot switch is subject to harsh operational environments and may eventually fail over the course of normal usage.No further actions are planned at this time related to the event.

• Brand Name: 9900
• Type of Device: FLUOROSCOPIC X-RAY
• Manufacturer (Section D): GE OEC MEDICAL SYSTEMS; 384 wright brothers dr.; salt lake city UT 84116
• Manufacturer Contact: 384 wright brothers dr.; salt lake city, UT 84116 ; 8015364952
• MDR Report Key: 4931055
• MDR Text Key: 6013413
• Report Number: 1720753-2015-02890
• 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: 07/20/2015

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: 06/25/2015
• Initial Date FDA Received: 07/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/21/2015
• 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