MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MULTITOM RAX; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number	10860700
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens local service engineer inspected the involved unit and was unable to reproduce the reported issue.According to the engineer, the system works as specified.The system is equipped with emergency stop button to prevent all unwanted system movement.There is a collision zone around the patient table to prevent the moving tube stand from hitting a patient positioned on the table.It is currently unclear where the patient was positioned at the time of the event.The force of the overhead tube is limited.Therefore, it is assumed that only a minor to moderate injury might occur if a person were to be hit under normal circumstances.The cause for the issue unclear and the investigation is on-going.A supplement report will be filed upon completion of the investigation.Internal id # (b)(4).
Event or Problem Description
Siemens became aware of unintended system movement of the multitom rax device.The 3d tube stand moved to position without given command.The user was preparing for a patient exam; when the exam was opened on the flc, the tube stand immediately started moving and aligned itself to a wall stand ogp (organ program) position, though, the examination was wrist complete.None of the ogps in this exam included wall positions.The reported issue occurred twice.Following the first occurrence, the system locked up in a wall position; the user had to reboot to attempt the examination again.During the second attempt, the system moved to a wall position again once the exam was opened, however, the unit did not lock up and the operator was able to move the tube stand manually to the correct position and complete the exam.The overhead tube avoided patient contact while in motion.There are no injuries attributed to this event.
Additional Manufacturer Narrative
The issue was investigated in detail.According to the information received, there was an unintended movement of the tube stand without operator input.It was communicated that as soon as the patient was selected on the flc, the system moved to wall positioning, even though the selected examination and the corresponding organ programs did not include any wall positioning.The issue occurred twice with the concerned unit.There was no contact or collision between the moving system and any person present in the room.The investigation of the log files showed that the ogp switch on the kick foot bar was pressed in both cases.The activation of the ogp switch on the kick foot bar can move the 3d tube stand to wall positioning, for example for centering, even in cases where wall positioning is not part of the exam.Siemens local service technician inspected the system at customer site but was unable to identify either any defect in the kick foot bar or system malfunction.The local service technician made the customer aware of the need to ensure that no one inadvertently activates a switch in the future as an unintentional activation of the kick foot bar could cause the reported issue.

• Brand Name: MULTITOM RAX
• Common Device Name: 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: 12306681
• Report Number: 3004977335-2021-91969
• Device Sequence Number: 3670814
• Product Code: OWB
• UDI-Device Identifier: 04056869009179
• UDI-Public: 04056869009179
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K152928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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
• Operator of Device: Health Professional
• Device Model Number: 10860700
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 11/23/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown