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

Model Number	10848281
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause for the stand issue has not yet been determined.The investigation is ongoing.A supplemental report will be submitted if additional information becomes available upon completion of the investigation.
Event or Problem Description
Siemens healthineers was informed by its service organization about an issue with the artis q ceiling system.The stand could not move.Additional information was provided stating that the malfunction occurred during an emergency procedure, which was continued and finished using an alternative system.Siemens healthineers has no indication of any adverse effects to the health status of the involved patient due to the reported issue.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed the investigation of the reported issue.The investigation was performed on expert discussions (considering complaint description, cs reports, system history, and system log files).At the beginning of an emergency procedure, the system messages ¿collision bypassed, move carefully.¿ was displayed to the user and normal system movements were not possible.The procedure was performed using an alternative system.No adverse health consequences were reported to this event.The onsite service intervention showed an issue with an end limit switches for the gantry longitudinal movement and c-arm orbital rotation.Due to this problem the stand could only be moved with reduced speed and the ceiling gantry could only be moved to the head-end for safety reasons.The log-file investigation revealed that this problem was present since the night before the reported movement problem.Dirty photo sensors were identified as the cause of the active limit switch signals.The reason for the contamination could not be determined retrospectively.The problem was resolved after the photo sensors of the end limit switches had been cleaned.The occurrence rate of the aforementioned 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 complaint has been closed.

• 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; forchheim 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 20500327
• Report Number: 3004977335-2024-00123
• Device Sequence Number: 15321257
• Product Code: OWB
• UDI-Device Identifier: 04056869009988
• UDI-Public: (01)04056869009988
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K181407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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: 10848281
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 11/11/2024
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown