MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AXIOM ARISTOS FX PLUS; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Model Number 10093864

Device Problem Unintended Movement (3026)

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

Event Date 05/26/2023

Event Type  malfunction  

Manufacturer Narrative

H10 manufacturer narrative: h3; h6: the investigation is ongoing.A supplemental report will be submitted to the fda if additional information becomes available upon completion of the investigation.

Event Description

The customer stated that the x-ray tube ran into the patient table with a patient on it.It was communicated that no injury or damage was caused by the incident.It was stated that the customer resolved the issue by replacing the table transvers potentiometer.The user has the possibility to stop system movement anytime by pressing the emergency stop button.Also, if the user lets go of the dmg button system movement will stop.No injury occurred in this case, but it is assumed that in worst-case scenario a minor to serious injury might be the outcome, for example if a person were hit at vulnerable parts of the body, should the issue recur.

Manufacturer Narrative

H3, h6: the described issue was investigated.It was initially stated that the x-ray tube ran into the patient table.According to the information provided, the issue was solved by third-party service contract holder with replacement of a defective or mis-aligned transverse table potentiometer.No further issues were communicated.No patient or customer has been injured.It is not known whether ge has performed any regular maintenance on the system.Despite several requests and reminders, further details about the issue could not be clarified because the customer did not accept siemens service.Siemens does not have a service contract for the affected system.The complaint issue cannot be investigated further based on the available information.Shs internal post market surveillance does not indicate a general problem for the affected table transverse potentiometer.In general, the user has the possibility to stop any system movement immediately by pressing the emergency stop button which is located on the right side of the patient table.Furthermore, system movements will stop as soon as the user releases the dmg key, even in the case of a faulty or misaligned table transverse potentiometer.The system axiom aristos fx plus has already reached eos (end of support) on 31.12.2021.The complaint is closed with this statement and without further measures.

• Brand Name: AXIOM ARISTOS FX PLUS
• Type of Device: SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr. 1 or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; 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: 17073624
• MDR Text Key: 317495185
• Report Number: 3004977335-2023-00036
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061054
• 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,Followup
• Report Date: 12/06/2023

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: Health Professional
• Device Model Number: 10093864
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/26/2023
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 12/06/2023
• 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