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	03/31/2022
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.Internal id # (b)(4).
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the artis zeego system.During system start-up for an emergency procedure, the user reported that no x-ray was available 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 sweden.
Additional Manufacturer Narrative
Siemens completed the investigation of the reported event.Additional information obtained from the customer reported a patient with abdominal bleeding had been allocated to a hybrid room where vascular surgery as well as open surgery is possible.The artis system was powered on for the emergency case; however, after boot-up, the system was not available for x-ray imaging.As the system obviously malfunctioned at startup, open surgery was chosen.It cannot be determined if the open surgery could have been avoided with a functional system.Three days after the event siemens service was informed about the malfunctioning system, only for troubleshooting and repair, which revealed the flat detector (fd) cooling unit had malfunctioned.The log file investigation confirmed that the fd cooling unit was malfunctioning at system startup and the user was shown a corresponding system message, no xray, fd warm up.The fd cooling unit was exchanged the issue was resolved.In the given case, the component had been in operation for about 10 years before the malfunction occurred.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.The event was considered in the risk analysis (delay/interruption of the clinical procedure, malfunction of a system component that does not have redundancy, functional and safety checks upon startup).The assessment of risks in connection with the hazard situation that has occurred remains valid.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: 15052942
• Report Number: 3004977335-2022-36470
• Device Sequence Number: 17515313
• Product Code: OWB
• UDI-Device Identifier: 04056869010083
• UDI-Public: 04056869010083
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2022

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 11/09/2022
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown