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

Model Number 10093902

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/13/2022

Event Type  malfunction  

Manufacturer Narrative

The reported issue occurred only once as the user decided to stop system usage until repairs.Siemens local service replaced the optigrip on the concerned unit.The part was requested for further investigation.Emergency stop button is always avaible to the user to stop all system movements.Investigation is on-going.A supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).

Event Description

Unintended system movement was reported on the axiom luminos tf system.When the user tried to perform collimation using the optigrip, the table started to drive / tilt upwards.There are no injuries attributed to this event.

Manufacturer Narrative

H10 manufacturer narrative: the complaint event was investigated in detail.It was initially reported that the system started to tilt upwards unintentionally when the collimation button on the optigrip was pressed on may 13, 2022 at 2 pm.According to the available information, the error occurred only once during patient operation.No patient was injured.The system was checked by a siemens service engineer.On arrival, the described system behavior was reproducible.According to the information from the service engineer, it was possible that the optigrip was cleaned before the failure.The optigrip was replaced on site.After replacement of the affected part, the problem was no longer reproducible.The spare part consumption of the affected part (material number: 10569552) shows values below the defined threshold.There is no indication for a systematic issue.Due to its architecture, only errors and warnings can be recorded in the log files for this type of system.The analysis of the provided log file shows that the system was restarted at 6.58 am and at 12.44 pm on the day of the incident.Several further entries are stored in the error log file.However, no connection with the optitop or tilting movement can be seen.The replaced optigrip was returned for further investigation.It was evident that only the center screw was mounted on the optitop, but no other screws were present.A crack was observed on the backside of the part.In addition, there is an impurity inside the optitop at the end.This could have been caused by fluid entering the optigrip.However, the crack and the impurity are outside the sealed area where electronic components are mounted.All other surfaces of the examined optigrip are in good condition, no other damage is visible.Furthermore, the buttons were checked.No deviation in the haptic or usage of the buttons could be found.None of the buttons got stuck after they were released.After the external visual inspection, the optigrip was opened.All gaskets (ipx4) were unharmed.No liquid residues were visible.The electronic component was correctly placed and mounted.None of the buttons were damaged.No damage was found in the area of the ip-protected housing either.This confirms that no liquid has entered.All buttons were correctly placed on the pcb (printed circuit board) inside the optigrip.To check their functionality, all snap disks were pushed.This test was passed successfully.For further investigation, the top cover of the optitop was then mounted to the lower part of another optigrip from a luminos agile max system (identical in construction for this component) to exclude mechanical failure for the described problem.All buttons were checked and worked as intended.None of the collimation buttons started to tilt the table.No problems could be detected.The described behavior could not be reproduced.The optitop was then cleaned with a disinfectant-soaked cloth and the test was repeated.All buttons still worked as specified and only the lights of the pushed buttons were on.After all these checks, the affected optitop was reassembled.To check the functionality of the electronic components, the optigrip was connected to the incoming goods inspection equipment.All buttons worked as specified.Only the lights of the pushed button were on.During investigation, no clear root cause could be determined for the described behavior.The failure was not reproducible.No malfunction of the replaced part was found and there is no indication of unintended movement in the error log file.No further occurrences are known after replacement of the optigrip.In case of an unintended movement the system has the emergency stop button, which shuts down all system drives, and all movements are stopped immediately.The complaint was closed and not further action by siemens was deemed necessary.H11 corrected data: b2: "other serious or important medical events should not have been checked in the initial report submitted to the fda on may 19, 2022.The reported event was not an adverse event.G2: report source should have been health professional in the initial report.This was not a user facility medwatch.

• Brand Name: AXIOM LUMINOS TF
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstr. 1 or rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 14453306
• MDR Text Key: 292198815
• Report Number: 3004977335-2022-28132
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2022

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?: Yes
• Initial Date Manufacturer Received: 05/13/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 12/21/2022
• Supplement Dates FDA Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other