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

Model Number	10280959
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
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operating the artis zeego system.During a procedure, the user reported that the robot-assised c-arm stopped when it was retracted.This triggered a collision alarm and no further movement was possible.The procedure was continued and completed on an alternate system.We are unaware of any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
Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware error.The detailed investigation showed that the fault occurred due to a temporary hardware failure.The cable connector of the limit switch, the proximity switch of the collision protection of the c-arm, had a bad contact which was detected by the technician on site.This led to the fact that the c-arm of the system could no longer be moved by motor at full speed, but for safety reasons only at reduced speed in the override mode.A corresponding error message is shown on the system.Radiation functions perfectly during this override mode.This mode is a mitigation of the problem.It runs under the conscious control of the user and is described in detail in the instruction for use (ifu).What caused the insufficient contact can no longer be determined retrospectively without doubt, however, external mechanical force on the cable connection is conceivable.In addition, it remains to be noted that the emergency button was also pressed on site which prevented further movements.It is not clear why the emergency button was pressed; however, accidental actuation can be ruled out, especially since the safety switch has an appropriate cover.After intervention of the local service department and completion of the final tests, the system was running again as specified.A possible general fault which would require corrective measures of the installed base could not be determined 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 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: 11307976
• Report Number: 3004977335-2021-65896
• Device Sequence Number: 1283921
• Product Code: OWB
• UDI-Device Identifier: 04056869010083
• UDI-Public: 04056869010083
• 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
• Remedial Action: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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: 10280959
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1