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

Model Number	10094139
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2020
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.During an interventional procedure, the user reports limited stand/table movement.The procedure was continued and finished using 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 investigate 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 defect.The proximity switch of the c-arm (collision protection) was damaged by external force and was permanently active.As a result, only slow movement (limited stand/table movement) of the c-arm was possible.Slow movement is a safety mode that allows, under the conscious control of the operator, to make further movements, even within the collision zone, when the collision computer is inactive.According to information provided by the customer, the operator accidentally drove the system onto the system's foot switch, damaging the system's collision mechanism as described.The operating instructions contain adequate instructions on how to handle the system in order to avoid endangering the patient, other persons and also the system itself.Explicit reference is made to the necessary attentiveness of the operator during this slow drive, where the collision computer is inactive.The affected part has been exchanged by the local service organization and the error did not reoccur.A systematic error of the system could not be detected by the examination.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: 10321154
• Report Number: 3004977335-2020-39285
• Device Sequence Number: 17015325
• Product Code: OWB
• UDI-Device Identifier: 04056869010076
• UDI-Public: 04056869010076
• Combination Product (Y/N): N
• 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 Health Care Professional
• Remedial Action: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2020

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: 07/22/2020
• Supplement Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1