MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH- AT ARTIS ICONO FLOOR; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number 11327700

Device Problems Display or Visual Feedback Problem (1184); Output Problem (3005)

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

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported event.A supplement report will be filed upon completion of the investigation.Internal id# (b)(4).

Event Description

It was reported to siemens that during an emergency procedure on the artis icono floor unit an x-ray image was pixelated.The image was unusable for diagnosis, and the procedure had to be completed on an alternate system.The reported event occurred in (b)(6).

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware error.The returned x-ray tube was examined at the factory and the small focus filament was found to be defective.Under normal conditions, each filament (emitter/heating element) has the same distance to the boundary plates surrounding it.However, thermal stress can have a negative effect on the position of the filament and the distance can decrease on one side.In the present case, the emitter was so close to the outer focal boundary that it touched the focal head, resulting in the unavailability of small focus x-rays.An x-ray tube is a wear part and filaments are the typical wear parts that limit the life of the tube.In such a case, the system will automatically switch to the next larger focus after pressing the foot switch three times as described in the user manual, resulting in a moderate degradation of image quality (e.G.Resolution / sharpness).Generally, acceptable residual functionality remains, yet in the given case the operator decided to finish the operation on another system.The affected x-ray tube has been exchanged on site by the local service organization and the error has not been reported again.The spare parts consumption was checked and a possible general fault that would require correction of the installed base could not be identified by the investigation.After detailed investigation, the incident is not classified as a reportable event as neither serious injury, death nor an unexpected prolonged hospitalization of the patient or any other person occurred or could be expected.

• Brand Name: ARTIS ICONO FLOOR
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10924598
• MDR Text Key: 220745675
• Report Number: 3004977335-2020-57139
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869149325
• UDI-Public: 04056869149325
• Combination Product (y/n): N
• PMA/PMN Number: K193326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11327700
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other