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

Model Number	10848281
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware of a malfunction while operating the artis q ceiling system.During an emergency patient procedure, the user was unable to release radiation.This system failure resulted in a long-term examination delay of a patient with a stroke.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.A supplement report will be filed if additional information becomes available.
Additional Manufacturer Narrative
The investigation was completed by our experts with the following results.Due to the system not releasing radiation and images not being visible on the live display, the procedure was cancelled, and the(b)(6) stroke patient was transferred to the intensive care unit.According to the additional information received, the patient was also suffering from pneumonia and needed respiration.The patient passed away on (b)(6) 2023, as a result of pneumonia.Siemens asked the customer to provide details on the clinical conditions to establish a relationship between the system failure and the patient¿s death.However, despite multiple attempts to collect data, the relationship could not be determined as the customer did not provide any information.Only an indirect connection between the stroke and the pneumonia is possible.The detailed investigation revealed that the image acquisition system (ias) went down abruptly without further logging activity hinting towards a possible hardware failure.The analysis of the log files revealed that the system switched to the bypass mode, where only continuous fluoroscopy with reduced image quality is possible, and the acquired scenes cannot be saved and reviewed later.The bypass mode is a mitigation for this kind of failure scenario; thus, a procedure can be aborted in a controlled manner if necessary.Normal functionality of the unit was restored approximately 2.5 hours following the error when the user manually restarted the system.The detailed log-file analysis did not reveal any information on why or how the system failed.According to the expert opinion, the possible root cause for the system failure is a loose gra (graphic ram) connection.After reseating the board, the system was fully functional and kept under observation.The error mentioned in the reported event has not re-occurred.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.
Additional Manufacturer Narrative
7/18/2024: supplemental mdr 2 was submitted to the fda for correction of the primary udi number in section d4.

• 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: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 18266462
• Report Number: 3004977335-2023-00158
• Device Sequence Number: 12722808
• Product Code: OWB
• UDI-Device Identifier: 04056869009988
• UDI-Public: (01)04056869009988(21)110252
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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,Followup
• Report Date (Section B): 07/18/2024

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
• 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: 11/28/2023
• Supplement Date Received by Manufacturer: 04/11/2024; 07/18/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 04/11/2024; 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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