MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS Q BIPLANE; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number	10848282
Medical Device Problem Codes	Mechanical Problem (1384); No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2022
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 if additional information becomes available upon completion of the investigation.Internal id #: (b)(4).
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the artis q biplane system.The user reported that no system movements were available during an interventional procedure.The malfunction occurred in the beginning states of the procedure.The medical procedure was terminated.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.The reported event occurred in norway.
Additional Manufacturer Narrative
H10: siemens completed the investigation of the reported event.The investigation was performed based on expert discussions considering the complaint description, customer service reports, system history, and system log files.It was reported that during an interventional procedure the stand and table movements were blocked.Unfortunately, a system restart did not resolve the issue.As a result, the user terminated the procedure.No adverse patient health consequences have been communicated to siemens regarding this incident.According to the customer, the incident could have resulted in serious injury to the patient if the malfunction had occurred under more unfavorable conditions.An on-site service intervention revealed a malfunctioning cable, connecting the examination control console (ecc) and the user location interface board.The affected part was replaced as part of service activity, which resolved the problem.The spare parts consumption of the defective cable was checked.Any accumulation of faults or even a possible general fault that would require corrective action of the installed base could not be determined by the investigation.The event that occurred was considered in the risk analysis (delay/interruption of the clinical procedure, malfunction of a system component that does not have redundancy, operation of the system and patient rescue when motorized movements are not possible).

• Brand Name: ARTIS Q BIPLANE
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1 or; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1 or rittigfeld 1; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 15502782
• Report Number: 3004977335-2022-46290
• Device Sequence Number: 7755432
• Product Code: OWB
• UDI-Device Identifier: 04056869009995
• UDI-Public: 04056869009995
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2023

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: 10848282
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown