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

Model Number	10280959
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2020
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 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 zeego system.During an interventional procedure, the user reported that the c-arm would not move.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 detailed investigation showed that the reported system behavior was caused by inaccurate adjustment parameters at the site.It is necessary to set these parameters on-site, as the individual conditions at the customer sites differ.For example, the actual distances to the walls, floor and ceiling must be entered for each individual site.If an error occurs here, the robot may assume that it has more space available (for example, to the floor), which ultimately leads to it moving into the defined safety area.This safety area is a specified protective function of the system.Normally, violation of this safety zone is not a major problem as the operator can drive out of it in the opposite direction using a special function, namely the override mode.This procedure is described in detail in the user manual and is also part of the user training.However, examination of the log file showed that this mode was not used at the time of the event, which is an indication that the above mentioned adjustment parameters were incorrect.For this reason, the on-site service organization was instructed to perform the adjustment again, so no further problems are expected.The system is operating as specified.

• Brand Name: ARTIS 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: 10553559
• Report Number: 3004977335-2020-45967
• Device Sequence Number: 16746576
• Product Code: OWB
• UDI-Device Identifier: 04056869010083
• UDI-Public: 04056869010083
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2020

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: 10280959
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/09/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1