MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH-AT ARTIS Q.ZEN BIPLANE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10848355
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2022
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 q.Zen biplane system.During a procedure, the user reported that x-ray was not available.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.
Additional Manufacturer Narrative
The investigation was performed based on expert discussions (considering complaint description, cs reports, system history, system log files, c-part).During a procedure, the system entered "bypass" mode.The "bypass" mode is a mitigation for different potential failure scenarios, so that a procedure can be aborted in a controlled manner if necessary.Since a reboot did not solve the problem, the upcoming procedure was performed using an alternative system.The problem was solved by siemens healthineers service by replacing the real-time computer (rtc) and the fiber optic cables of the imaging systems.Log file analysis as well as the rtc investigation confirmed a hardware defect in the rtc.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 incident described in the event was not classified as a reportable adverse event after detailed investigation.Neither serious injury, death nor an unexpected, prolonged hospitalization of the patient or any other person occurred or could be expected.The corresponding probability according to the risk analysis is in the range of inconceivable.

• Brand Name: ARTIS Q.ZEN BIPLANE
• 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; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 14101111
• Report Number: 3004977335-2022-23803
• Device Sequence Number: 4789131
• Product Code: OWB
• UDI-Device Identifier: 04056869010038
• UDI-Public: 04056869010038
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2022

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: 10848355
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2022
• Supplement Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 07/22/2022
• 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
• Patient Sex: Unknown