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

Model Number	10094139
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2020
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 follow-up report will be filed upon completion of the investigation.
Event or Problem Description
It was reported to siemens that an error occurred while using the artis zee multi-purpose system.The user reports sporadical unintended table movement.We are unaware of any impact to the state of health of the patient involved.Siemens has requested additional information in order to investigate the reported event.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.Assessment of the log files does not indicate a system failure or malfunction and no non-conformity was identified.According to the customer, the system was driving towards the ceiling and it was not possible for the operator to drive down again.However, examination of the log files showed that the operator was able to use the so-called "override mode" and drive in the opposite direction at any time.The override mode described in the manual is a safety mode that allows the operator to drive out of the collision zone under his supervision and at reduced speed.The log file also shows that this safety mode has been used.It is possible that this statement only refers to the "auto mode function".With this function, previously stored positions are automatically approached as required.The "auto run" can be aborted at any time and "override mode" is also available.The error described could not be reproduced and the investigation did not give any indication of a necessary change in the software.The affected system was inspected on site by the local service organization.However, no system error could be detected.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 ZEE MULTI-PURPOSE
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH - AT; siemensstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10289416
• Report Number: 3004977335-2020-35807
• Device Sequence Number: 11018040
• Product Code: OWB
• UDI-Device Identifier: 04056869010076
• UDI-Public: 04056869010076
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2020

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: 10094139
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1