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

Model Number	10280959
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported to siemens that a malfunction occurred while operating the artis zeego system.During an interventional procedure, the user reported that the system was driving with slow speed.As a result, full restart of the system caused a delay of 20 minutes.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.
Additional 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.During an interventional procedure, the system could only be moved slowly.The error message "reduced stand/table speed" was displayed to the user.The procedure could and was continued and finished on the imperfect system.To fix the problem, the user rebooted the system, unfortunately without success.According to the information provided, the reboot was performed during a procedure.This conclusion cannot be made based on the log files.According to the logs, the reboot was performed 2 hours after an x-ray session and 2 hours before the next x-ray session.The next day, technicians of the hospital, with telephone support from cs, investigated the system and log files and determined an issue with the potentiometer for the flat detector (fd) lift and that some oil was on the tooth belt of the fd lift.The detailed analysis of the log file confirms an issue with the potentiometer.The system has automatically detected an issue by means of comparing the first source of information (in this case: encoder) with the second source of information (in this case: potentiometer).When the defined tolerance for the deviation was exceeded, the system switched to "reduced stand/table speed" and displayed the corresponding error message to the user.As a result of the mismatch, only slow system movement was possible to avoid system collisions, but still able to move the system so that a procedure can be aborted in a controlled manner or, as in this case, finished.According to experts, the problem with the potentiometer may be due to a defect in the potentiometer itself, or that the belt "slipped" from its correct position due to the oil on the tooth belt, causing the mismatch.After replacing the potentiometer module with the tooth belt, the system works as intended.The occurrence rate of the error pattern was checked.A possible error accumulation or even a systematic error, which leads to a corrective action of the installed base, could not be determined 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 ZEEGO
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1- or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 14759310
• Report Number: 3004977335-2022-32239
• Device Sequence Number: 1294350
• Product Code: OWB
• UDI-Device Identifier: 04056869010083
• UDI-Public: 04056869010083
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K181407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2022

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
• Operator of Device: Health Professional
• Device Model Number: 10280959
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown