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

Model Number 10093902

Device Problems Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)

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

Event Date 10/25/2023

Event Type  malfunction  

Event Description

Siemens healthcare was made aware that there is damage to the system patient table.Provided pictures show a hole in the cover of the table frame and a bent metal frame bracket.No injury occurred in this case.The collision must have been massive based on damages shown in the pictures.It is assumed that in a worst-case scenario a minor to serious injury might have been the outcome if a person had been lying on the table at the time of collision or had been caught between the system and an external object.Further information was requested for investigation but has not yet been received as of the date of this report.

Manufacturer Narrative

Initial corrective actions/preventive actions implemented by the manufacturer: it was requested that the facility not use the system until repair is completed.No general problem has been detected for the installed base which requires an immediate action.Manufacturers preliminary analysis: based on currently available information no system malfunction was determined.There are clear indications that the issue was caused by a collision with an external object due to operator inattentiveness.The investigation is ongoing.A supplemental report will be submitted if additional information becomes available upon the completion of the investigation.

• Brand Name: AXIOM LUMINOS TF
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 18064321
• MDR Text Key: 327249963
• Report Number: 3004977335-2023-00143
• 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
• Type of Report: Initial
• Report Date: 11/03/2023

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
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1