MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH- AT ARTIS ZEEGO; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10280959

Device Problem Mechanical Problem (1384)

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

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.

Event Description

It was reported to siemens that a malfunction occurred while operating the artis zeego system.During an interventional procedure, the system stopped moving and the user saw the collision control deactivated message.The procedure was continued and completed on an alternate system.We are unaware of any impact to the state of health of the patient involved.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware error.The investigation was performed considering complaint description, cs reports, system history, and system log files.The detailed investigation showed that the issue was due to communication problems between different system components.As to the information provided in the initial report that the system stopped moving; this could not be confirmed by the investigation.The investigation showed that table movement and x-ray functionality was still possible.Furthermore, stand movement was also possible when using the override mode.After trouble shooting by the customer service engineer, there were no further issues, and the system works as intended.The cause of the error could not be determined with certainty in retrospect.In the opinion of the technical expert, the most likely cause is a loose contact on a pc fan that was removed by the service technician.This led to temporary overheating of electronic components which resulted in the communication problems reported.The occurrence rate of the identified cause has been checked and no error accumulation has been identified.The occurrence rate is below the defined threshold and no corrective action is necessary.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 ZEEGO
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 12195585
• MDR Text Key: 262476011
• Report Number: 3004977335-2021-88228
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869010083
• UDI-Public: 04056869010083
• Combination Product (y/n): N
• PMA/PMN Number: K181407
• 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: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10280959
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1