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

Model Number 10093902

Device Problem Unintended Movement (3026)

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

Event Date 02/06/2023

Event Type  malfunction  

Event Description

An untrained customer inhouse engineer replaced the motor for table movement with the patient table in vertical position without securing the table in longitudinal direction before removing the motor.Without the motor there is no brake function, and the patient table could hit the floor due to gravity.Even though the service engineer was most likely standing behind the system during the service activity, if another person had their foot between the table and the floor at this time, a serious injury could occur in a worst-case scenario.In this case no injury occurred.

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be submitted if addition information becomes available upon completion of the investigation.

Manufacturer Narrative

H3, h6: the described issue was investigated in detail.According to the provided information, the table hit the floor during motor replacement.No injury was communicated.Additional information was received during the investigation regarding the workflow during which the issue occurred.The table was tilted at plus 88 degrees (vertically) when the untrained in-house engineer wanted to replace the defective motor used for moving the system longitudinally.The in-house engineer did not secure the table longitudinally before removing the motor.The in-house engineer released the motor, deactivated its braking function.This enabled gravity to pull the table downward.The table slid approximately 3 to 5 cm until it hit the floor.Covers and system components were damaged.The in-house technician was alone in the room while performing the service activity.After the incident, a siemens service engineer repaired the system.During the repair, two error messages were displayed: error 128/32: indicating a cable break at connector 1 error 311/32: indicating that a deviation of the potentiometer value was detected when the system was switched on and the system was blocked.According to the information received, the potentiometer r150, the foot switch, a roller for the grease band routing and the cover for the rollers and the grease band were damaged because of the incident.The mentioned error messages were caused by the collision with the floor, which resulted in a defective potentiometer r150.The damaged parts, including the affected motor, were replaced on site.The system is now fully operational.The spare part consumption of the concerned motor (material number 07063811) was checked.No general problem was found.There is currently no manual available for the replacement of this motor.Therefore, a manual for the correct replacement of this motor will be prepared and added to the spare parts in stock (planned release: end of october 2023).However, it is described in the service documents (axiom luminos tf field service strategy, axd1-300.890.01.02.02, page 17) that service activities, including the motor replacement, may only be performed by trained personnel.The complaint has been closed.

• Brand Name: AXIOM LUMINOS TF
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr. 1 or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 or; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 16426579
• MDR Text Key: 310162446
• Report Number: 3004977335-2023-00012
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

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: Other
• Device Model Number: 10093902
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 02/23/2023
• Supplement Dates Manufacturer Received: 08/07/2023
• Supplement Dates FDA Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1