MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AXIOM LUMINOS TF; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number 10093902

Device Problem Radiation Overexposure (3017)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 10/27/2016

Event Type  malfunction  

Manufacturer Narrative

The system was checked by local service.The engineer installed new opti-grip handle, replaced inverter as well as high voltage tank and completed tube and generator calibrations.The concerned system was brought back to specifications.The replaced parts were sent to the factory for further investigation.A supplemental report will be submitted if additional information becomes available.This report was submitted november 11, 2016.

Event Description

An unintended radiation release on the axiom luminos tf system was reported (b)(6) 2016.The radiation technician released the trigger during the exam, however the system continued to release radiation with a patient on the table.The technician had to press emergency stop button to shut down the unit.

Manufacturer Narrative

The investigation showed that the described issue was caused by a defective control handle with a sticking button.Provided log files confirmed that the activated button had been recognized at the restart of the system and the related function had been blocked.The affected component was reworked and checked at the supplier.The spare part consumption of the affected part was checked and showed normal values.No general problem was determined.At the concerned site the affected control handle was replaced by the local service organization.This report was submitted (b)(6) 2017.

• Brand Name: AXIOM LUMINOS TF
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd, mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 6095730
• MDR Text Key: 60236505
• Report Number: 2240869-2016-59485
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K051602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/28/2016

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: 10093902
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/28/2016
• Initial Date FDA Received: 11/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/11/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other