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

Model Number 10094200

Device Problem Unintended Movement (3026)

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

Event Date 11/14/2021

Event Type  malfunction  

Manufacturer Narrative

The concerned unit was inspected by siemens local service.Siemens engineer replaced an electronic board and deactivated a joystick for tilt movement in the control room as a precaution.System malfunction currently could not be identified.The joystick was requested for further investigation.System motion can always be stopped by the user by pressing the emergency stop button.Siemens is conducting a thorough investigation of the reported incident.A supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).

Event Description

Unintended system movement was reported for the axiom luminos drf unit.The machine tilted without given command.There are no injuries involved in this event.The reported event occurred in (b)(6).

Manufacturer Narrative

The described issue was examined.According to the available information, there were no injuries associated with the event, but, for safety reasons, the rad controller d801 (10140508) was replaced oat the concerned site.A detailed log file analysis by siemens experts, however, did not show any errors pointing to an unintended movement, since there were no signs of malfunction or internal triggered movements in the analyzed data.Therefore, a defective rad controller was excluded as a root cause of this issue.Consequently, an unintended actuation of the tilt movement joystick at the remote-control console would be the most likely cause for an unintended movement.However, based on the data analysis it could be concluded that the joystick worked according to the specifications as the dmg signal was required to trigger the movement.The described malfunction could not be reproduced based on the provided log files.Considering the consumption of the spare parts, which are below the defined thresholds, no indication to a systematic problem was given.Based on this knowledge and the analysis undertaken, the remaining possible cause is unintentional operation by the user.Additional information was provided that the problem could not be reproduced on site.Therefore, since the incident occurred only once and was not reproducible and no malfunction or general problem was found the complaint is closed without further measures.

• Brand Name: AXIOM LUMINOS DRF
• 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; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 12859973
• MDR Text Key: 282730943
• Report Number: 3004977335-2021-05154
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

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: 10094200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2021
• Initial Date FDA Received: 11/23/2021
• Supplement Dates Manufacturer Received: 05/05/2022
• Supplement Dates FDA Received: 05/09/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other