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

Model Number	10848355
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
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 an interventional procedure, the user reported that no x-ray was possible.The procedure was not continued.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 system shutdown during an installation process.Due to an unexpected system behaviour, the automatic start of a software update was postponed.The log analysis showed that the system had been switched off by the user (hard powered off) during the last system backup, which resulted in a corruption of the hp system file in which the patch installation information was stored.The corrupted file in the hp environment started, but the information that the vd11c patch11 was already installed was missing.This led to a new installation process, which was interrupted and aborted by the user by shutting down the system, which brought the system into the error status of an inconsistent configuration.Although the configuration was restored as part of a reactive service activity, which allowed the system to be brought back into operation, the corruption of the hp system file was not detected in the process.This resulted in the information of the already installed vd11c patch11 still being missing in the hp environment.The system software was completely reinstalled as part of service activity which resolved the error of the corrupted hp system files.A possible general error, which would require corrective action of the installed base, could not be identified 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 Q.ZEN BIPLANE
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 6104486461
• MDR Report Key: 12494667
• Report Number: 3004977335-2021-96523
• Device Sequence Number: 3289023
• Product Code: OWB
• UDI-Device Identifier: 04056869010038
• UDI-Public: 04056869010038
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2021

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: 09/09/2021
• Supplement Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 11/15/2021
• 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