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

Model Number	10848283
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
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.Zeego system.During an interventional procedure, the user reported that c-arm movement was not possible.The procedure was continued and completed on an alternate system.During transfer to an alternate table, the sheath in the patient was pulled out.Pressure was applied to stop bleeding.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 user error.In a robotic system, two room limitations for the range of motion are active.The first being the "stand control units" (scu) set limits (room limits).When reaching those, the user is informed but still able to drive the system away from the borders of the allowed movement area.The second set of limits are the robotic internally set limits (saferdw limits) which are slightly higher than the scu room limits.In regular operation, the user is unable to drive into the saferdw limits.In the event the robot is driven beyond the saferdw limits (e.G., provoked by a system issue or an issue with the room limits) further movement is blocked for safety reasons.If limits are breached, it is only possible to drive the robot out of the "saferdw limits" as part of reactive service activity.It could be determined that the zeego system had an issue with the room limits.The user received the error message "stand/table error, call sc" but was still able to move the system.In this erroneous scenario, the customer was advised to reset the scu.Unfortunately, the scu was not reset, and the robot could and was driven into the "saferdw limits".As a result, further robot movement was blocked, and system operation could only be restored as part of service activity.After the reactive service intervention, the error did not occur again.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.ZEEGO
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 12377035
• Report Number: 3004977335-2021-93587
• Device Sequence Number: 11746218
• Product Code: OWB
• UDI-Device Identifier: 04056869010007
• UDI-Public: 04056869010007
• 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,user f
• Initial Reporter Occupation: Other
• Remedial Action: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

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: 10848283
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1