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

Model Number	10848353
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2020
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 q.Zen floor system.During an interventional procedure, the user reported that the system locked up.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 sporadic error described in the complaint occurred twice in a row, at different times.The first incident was on (b)(6) 2020 and is identified with pm00249096.The second incident was on (b)(6) 2020 and is identified with pm00252187.Each of these incidents resulted in a service intervention where the actual error was finally rectified by the second service intervention on (b)(6) 2020.The cable control module (tcm) was initially replaced during the first service intervention as the error pattern on site and the log file entries indicated this.During the second service visit, the error was narrowed down further and the associated cable (control module cable) was identified as the cause of the error and was replaced.Since exchanging the affected tcm and cable by the local service organization, the error has not been reported again.A possible general error, which would require corrective action of the installed base, could not be identified 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 Q.ZEN FLOOR
• 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: 10641735
• Report Number: 3004977335-2020-49096
• Device Sequence Number: 2901272
• Product Code: OWB
• UDI-Device Identifier: 04056869010014
• UDI-Public: 04056869010014
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 10/07/2020

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: 10848353
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1