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

Model Number	10848282
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
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.Internal id # (b)(4).
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the artis q biplane system.During an interventional procedure, a stent was inserted, however, the user was unable to see the location of the stent.The procedure was continued and successfully completed on the same unit.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 (b)(6).
Additional Manufacturer Narrative
Siemens conducted a detailed investigation of the reported event.The investigation was performed on expert discussions (considering complaint description, cs reports, system history, system log files).During an interventional procedure, x-ray imaging was no longer possible with the roadmap function.Normal operation of the system was restored by a "power cycle," i.E., the system was shut down and turned back on so that the associated components were restored to normal.Thereafter, the procedure was continued and completed on the system.The log file investigation revealed that the customer has performed a roadmap.[technical note: roadmaps are subtracted angiography images that facilitate navigation through the vessels during further fluoroscopies.] during the roadmap, the user moved the stand.The movement reset the current roadmap progress on plane a, but incorrectly did not reset it on plane b.As a result, no x-ray was possible on both planes and the user could not deactivate roadmap either.The system message "new values rejected: during fluoro" was displayed.The instructions for use warn the user not to move the patient, the table or the system during a roadmap acquisition, as the reference and the current image would no longer match and the roadmap function can therefore no longer be used.If the system is moved during a roadmap acquisition, the user can usually reset the roadmap functionality.In this case, resetting the roadmap functionality was not possible due to a software error.Even though the problem could not be reproduced in factory tests, the root cause of the problem was identified in the source code, which can sporadically cause the described problem.The instruction for use gives adequate instructions how to handle the system in this kind of erroneous scenarios, which were followed by the user accordingly: at ~13:22, the aforementioned problem occurred, whereupon the user tried to resolve the issue by pressing and pulling the emergency button and resetting the stand control unit (scu), without success.However, the system switched to "bypass fluoro" mode for 2 minutes, in which only continuous fluoroscopy is possible on a bypass display and the acquired scenes cannot be saved and reviewed.Several images were acquired in "bypass fluoro" mode.At ~13:28 the system was shut down, which was finally off at ~13:30.At ~13:40 the system was switched on and was operational again at ~13:43.The power cycle resolved the problem.At ~13:45 the user started using x-ray.We have been informed that the patient is on the neuro-rehab ward.We have no further information on the patient's current state of health.Based on the information that was made available to us, it is not possible to assess whether and to what extent the system failure contributed to adverse health effects.Internal id # (b)(4).

• Brand Name: ARTIS Q BIPLANE
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 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: 14407626
• Report Number: 3004977335-2022-26931
• Device Sequence Number: 2430172
• Product Code: OWB
• UDI-Device Identifier: 04056869009995
• UDI-Public: 04056869009995
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 05/16/2022
• Supplement Report FDA Received Date: 08/19/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown