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

Model Number	10094139
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.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 during an interventional procedure using the reported artis zee system c-arm was colliding with the floor and the black collision strips were not working.The procedure was continued and finished using an alternative system.There was no report of adverse effect to the health status of the patient.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be a user error.The detailed investigation revealed that the damage was caused by the operator.The operator moved the c-arm toward the ground.In doing so, he came so close to the ground that the collision computer responded and warned of a possible collision.A corresponding message was displayed on the monitor.Due to a built-in protection system, further movements of the c-arm towards the ground were only possible in override mode from this point on, which is described accordingly in the operating instructions.This mode is a special protective device to give the customer full control in critical situations.The collision computer of the system is switched off to be able to move the c-arm out of the danger zone under the care of the operator.The operator continued to move the c-arm toward the ground despite the warning.Eventually, the safety switch responded as contact was made with the ground.The system stopped as specified and reported the collision.The operator did not drive out of the collision area afterwards; but drove the c-arm onto the ground again using the override mode.In the process, the safety switch was eventually damaged which ultimately required intervention by local engineering.The safety switch was replaced by the local service organization and no further errors have been reported.A possible fault in the system or a general fault that would require corrective action by 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 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: 11024009
• Report Number: 3004977335-2020-59012
• Device Sequence Number: 13641447
• Product Code: OWB
• UDI-Device Identifier: 04056869010076
• UDI-Public: 04056869010076
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,health
• Initial Reporter Occupation: Other
• Remedial Action: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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: 12/07/2020
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 12/16/2020
• 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