MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG ARTIS Q CEILING; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10848281
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/27/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Siemens became aware of an incident that occurred while operating the artis q ceiling system.It was reported that the overlay of the angio and ct systems showed an offset of 6 cm.Additional information was provided that during a patient procedure a marking for needle guidance showed a difference of 6 cm, resulting in mistakenly stabbing the patient's stomach wall, causing bleeding.Detailed clarifications of this event are currently ongoing.
Additional Manufacturer Narrative
Additional information was received that the procedure was successfully completed without any further problems.The involved patient was not seriously injured by the operator¿s error.Despite all efforts, the conducted investigation did not reveal the cause of the observed problem.As a preventive measure, siemens local service performed calibration of the angio ct.The reported issue has not again been reported since the first occurrence.Since an overlay error (i.E.Position mismatch) between the live fluoroscopy and the overlaid image cannot be completely ruled out, e.G.Due to possible organ movements, the operating instructions contain adequate steps on how to work with overlays.The users are instructed to check whether the overlay is displayed in the correct position before starting the procedure.A possible general error that would require corrective measures of the installed base could not be determined by the investigation.

• Brand Name: ARTIS Q CEILING
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1 -or-; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1 -or-; rittigfeld 1; forchheimforchheim 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 21334951
• Report Number: 3004977335-2025-00020
• Device Sequence Number: 19772636
• Product Code: OWB
• UDI-Device Identifier: 04056869009988
• UDI-Public: (01)04056869009988
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 10848281
• 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: 02/04/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown