MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG ARTIS ZEE BIPLANE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10094141

Device Problems Insufficient Information (3190); Activation Failure (3270)

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

Event Date 01/23/2024

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported event.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed if additional information becomes available.

Event Description

Siemens became aware of a malfunction that occurred while operating the artis zee biplane system.During an emergency patient procedure, the user was unable to move the stand to either a or b plane.The patient had to be moved and the procedure was completed on an alternate unit.We have no indications of any adverse effects on the health status of the involved patient.

Manufacturer Narrative

Siemens has completed an investigation of the event.The root cause was determined to be a hardware error.The investigation was performed considering complaint description, cs reports, system history, system log files, and complaint part analysis.During an emergency procedure system movement was possible only with reduced speed.The procedure was then performed using an alternative system.The onsite service intervention revealed a problem with the motor controller module (mcm) of plane b on a biplane system.As a result, the system could be moved with reduced speed only and system messages ¿reduced stand/table speed¿ and ¿collision control deactivated¿ were displayed to the user.To resolve the issue, the mcm was exchanged and detailed investigation of the defective part showed a failure of the low voltage power supply.The spare parts consumption of the defective power supply was checked.Any accumulation of faults or a possible general fault that would require corrective action of the installed base could not be determined.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 ZEE BIPLANE
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; 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: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 18630890
• MDR Text Key: 334501679
• Report Number: 3004977335-2024-00012
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869010069
• UDI-Public: 04056869010069
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K181407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10094141
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• 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