MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH, ADVANCED THERAPIES AXIOM ARISTOS MX/VX; SYSTEM, X-RAY, STATIONARY

Model Number 5895003

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Siemens local service organization is working on resolving the issue with the system.A supplemental report will be submitted if additional information becomes available.

Event Description

It was reported that a table of the axiom aristos system went all the way down during the night.The system was off, however, the led lights and the opto isolator had power.There are no injuries attributed to this event.

Manufacturer Narrative

**resubmission of follow-up report as per fda on (b)(6) 2020** the investigation for the reported issue was completed.It was determined that the can communication was disturbed by collimator cable.Errors on can bus have been recognized by the system.The complaint part d54 board was installed on the test system and checked for correct functionality.The table was moved several times a day for a period of time; the position would be documented and checked the next day for any unexpected movements.The behavior was been observed for 7 days.Further the event log has been reviewed for any errors.No malfunction of the board was recognized.The returned part did not show any error.The concerned d52, d53 leds are located on the tomo-controller and are not linked to the table movement (only 3d and detector bucky).If the led status is still not okay, after replacement of the d54 it has to be investigated by local service according to the latest circuit diagrams.At this time we exclude any relation to the table movement.Unintended movement is technically prevented by the dead man switch principal, which means, that the user has always to push a button/switch to activate system movements.This principal is controlled by software/firmware getting the relevant system information (e.G.Button status) by the can bus communication protocol.Therefore the only possible root causes are: - movement released manually (e.G.Pushing the table down foot switch) or - severe communication disturbances on the can bus which may lead to unexpected system errors.In case this unpredictable situation leads to a malfunction with movements the emergency button allows the operator to interrupt any movement by pushing the emergency button which cuts the power of the motor.While investigating the error log it has been confirmed, that the system had severe can bus troubles at time of the incident which has also be displayed on the imaging system.No general problem has been detected.Existing safety measure of the emergency stop button is available to prevent unintended system movements.

• Brand Name: AXIOM ARISTOS MX/VX
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH, ADVANCED THERAPIES; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 8560197
• MDR Text Key: 145917578
• Report Number: 3004977335-2017-84235
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• PMA/PMN Number: K061054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5895003
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/14/2017
• Initial Date FDA Received: 04/29/2019
• Supplement Dates Manufacturer Received: 10/24/2017
• Supplement Dates FDA Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other