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

Model Number	10848282
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2022
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 biplane system.During an emergency procedure, the user reported an error with the bypass module.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 completed the investigation of the reported system and event.The artis system switched into bypass mode, in which continuous fluoroscopy with reduced image quality is available, but the acquired scenes cannot be saved and reviewed.The "bypass" mode is a mitigation for different potential failure scenarios, so that a procedure can be aborted in a controlled manner if necessary.During on-site troubleshooting an issue with the bypass module was detected.The module was exchanged as part of service activity, which resolved the problem.A detailed investigation of the module by the manufacturer did not reveal any defect.Therefore, a clear root cause could be determined.According to the system expert, there was most likely a temporary and non-reproducible problem with the bypass module or the plug contacts of the bypass module.The occurrence rate of the error pattern was checked.A possible error accumulation or even a systematic error, which leads to a corrective action of the installed base, could not be determined by the investigation.The incident described in the event was not classified as a reportable adverse event after detailed investigation.Neither serious injury, death nor an unexpected, prolonged hospitalization of the patient or any other person occurred or could be expected if the event were to recur.

• Brand Name: ARTIS Q BIPLANE
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH - AT; siemensstr. 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 14351074
• Report Number: 3004977335-2022-26430
• Device Sequence Number: 19869471
• Product Code: OWB
• UDI-Device Identifier: 04056869009995
• UDI-Public: 04056869009995
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2022

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2022
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 08/17/2022
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown