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

Model Number	10280959
Medical Device Problem Codes	Output Problem (3005); Radiation Output Problem (4026); Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2022
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.Internal id # (b)(4).
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 no x-ray was available and an exposure was not possible.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.The reported event occurred in norway.
Additional Manufacturer Narrative
Siemens conducted a detailed investigation of the reported event.The investigation was performed on expert discussions considering the complaint description, customer service reports, and system history.According to the available information, the system reported an over temperature of the x-ray tube during an interventional procedure.However, the user continued the procedure.After a few more x-ray series, the error message "tube too hot" was displayed and x-ray imaging was no longer possible.As a result, the patient was moved to another lab which caused a delay in patient treatment and "significantly established infarct changes and clinically persistent stroke score of about 19 (nihss 19)" was communicated.To resolve the issue, the customer exchanged the water pump of the tube colling system.Siemens service was not called to troubleshoot the system.Neither the defective pump nor the log files were available for a detailed investigation.Therefore, it is not possible to determine how and why the colling unit pump was damaged.The general system behavior in case of a malfunction of the x-ray tube cooling unit activates a multi-stage detection and warning mechanism, so that the system displays the message "tube hot, have a break" for the user.If, despite the messages, the user continues x-ray imaging, the temperature may exceed a second temperature threshold of the oil pressure may increase until the limit, where a hw switch is activated and disables x-ray imaging for safety reasons (potential burst of the x-ray tube).The system displays the message "no xray, tube too hot".The occurrence rate of the aforementioned 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.H11: b2: other serious or important medical events was checked in error on the initial report submitted on august 31, 2022.Internal id # (b)(4).

• Brand Name: ARTIS ZEEGO
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1 or rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 15045074
• Report Number: 3004977335-2022-36116
• Device Sequence Number: 12492498
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown