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

Model Number	10848280
Medical Device Problem Code	Operating System Becomes Nonfunctional (2996)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
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.
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the artis q floor system, during an emergency procedure, the system froze and was not operable.The procedure had to be cancelled by the user.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.
Additional Manufacturer Narrative
H3, h6: the investigation was performed based on expert discussions considering complaint description, customer service reports, system history, and system log files.According to the provided information, x-ray was not possible during an emergency procedure.No health patient consequence was reported to this event.Log-file investigation showed that x-ray was possible in fluoro-mode.However, ¿store fluoro¿ and x-ray was not possible in acquisition mode.The cause is found to be that the image disk was full and there was not enough space to creating image file, which resulted in no images being saved.As the imaging system is not an archiving system, deletion of old patient data periodically is required to avoid full memory.The message "memory full, delete patients" message was displayed to the user.The instructions for use provide adequate guidance for proper use in the event of this message.To resolve the problem, old patient data was deleted.No malfunction of the system could be detected.

• 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 HEALTHCARE GMBH; 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: 17710365
• Report Number: 3004977335-2023-00109
• Device Sequence Number: 16681633
• Product Code: OWB
• UDI-Device Identifier: 04056869009971
• UDI-Public: 04056869009971
• 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
• Report Date (Section B): 09/30/2023

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: 09/01/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 09/30/2023
• 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