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

Model Number	10848280
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.A supplemental report will be filed upon completion of the investigation.
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the artis q floor unit.During an emergency cardiovascular procedure, x-ray release on the system was unavailable.The procedure was delayed for approximately 15 minutes and then continued following complete system reboot.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
The investigation of the reported event was completed by our experts.Detailed analysis revealed that the graphic ram (gra) driver experienced an error preventing release of x-ray during the procedure.All options for x-ray release were unavailable due to this issue (e.G., footswitch and handswitch).The warning message ¿no fluoro, try again¿ was displayed to the user.The system was restarted by the user; however, it did not recover immediately.The error message ¿fd not ready¿ was displayed to the user during the system reboots.It took the system several minutes to recover and then the procedure was continued.The root cause for the issue was identified as ias-a hardware (gra board) failure.All boards were reseated, and all network connections were checked as part of service actions to prevent any future reoccurrences.The reported error has not reoccurred since the service activities.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
7/19/2024: supplemental mdr 2 was submitted to the fda for correction of the primary udi number in section d4.

• Brand Name: ARTIS Q FLOOR
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; 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: 18208925
• Report Number: 3004977335-2023-00155
• Device Sequence Number: 20397111
• Product Code: OWB
• UDI-Device Identifier: 04056869009971
• UDI-Public: (01)04056869009971(21)104045
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2024

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: 10848280
• 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: 11/15/2023
• Supplement Date Received by Manufacturer: 03/05/2024; 07/19/2024
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 03/05/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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