MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AXIOM ARISTOS FX PLUS; STATIONARY X-RAY SYSTEM

Model Number 10093864

Device Problem Use of Device Problem (1670)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 03/12/2020

Event Type  malfunction  

Manufacturer Narrative

It was identified that the issue was caused by a systematic hardware error of the circuit board.The affected circuit uses an integrated circuit (ic) that has not been modified since the development of the board.However, it was determined in a specific batch of d1 boards manufactured in 08/2017, the ic appears to cause signal deformations.The ic may generate an oscillating circuit while remaining within the defined tolerances.Since the error is not known from the installed base using boards manufactured before 2017, it is concluded that the ic uses a broader range of the tolerances (used starting 2017) and, thus, leads to the signal deformation.The concerned unit was shut down until further repairs.Siemens local service engineer installed a d1 board with revision level 3.No further issues have been reported since the repairs were performed.Internal id # (b)(4).

Event Description

Siemens became aware of an incident that occurred on the axiom aristos fx plus system.One patient received three (3) radiation exposures - one (1) intended and two (2) unintended.The system performed exposures without the exposure button being pressed.The exposure dose released was less than 500ms, therefore, the overall dose is estimated at 0.01msv.The additional dose received is not considered injurious.There are no injuries attributed to this event.The reported incident occurred in (b)(4).

• Brand Name: AXIOM ARISTOS FX PLUS
• Type of Device: STATIONARY X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkesstrasse 127; erlangen 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; henkesstrasse 127; erlangen 91052 ; GM 91052
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, pa ; 4486478
• MDR Report Key: 9889490
• MDR Text Key: 191285363
• Report Number: 3002808157-2020-23239
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K013826
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 10093864
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2020
• 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