MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS Q CEILING; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number	10848281
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2022
Type of Reportable Event	Malfunction
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 upon completion of the investigation.Internal id # (b)(4).
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the artis q ceiling system.The transmission of 3d image of cone-beam computed tomography (cbct) failed during an interventional procedure, according to the user.The procedure was continued and completed on the concerned unit.Siemens is not aware of any adverse effects on the health status of the involved patient.Siemens has requested additional information in order to conduct an investigation of the reported event.The reported event occurred in china.
Additional Manufacturer Narrative
According to the description, following a 3d acquisition, the scene could not be successfully transferred to the workplace for 3d reconstruction.The reported issue was related to the 3d transfer and 3d reconstruction of the 3d acquisition only.All basic system functions remained available (e.G.2d fluoro/acquisition, system movements, image display) to the user.Restart of the dicom network switch, which is installed between the artis and the workplace system, resolved the issue.The procedure was then continued and completed successfully.The reported error has not re-occurred.Our experts checked the occurrence rate of the reported error pattern.Possible error accumulation or systematic error, which may lead to a corrective action of the installed base, could not be determined by the investigation.The incident described in the adverse event is not classified as a reportable event after a thorough investigation because neither serious injury, death, nor unexpected prolonged hospitalization of the patient or other person occurred or is to be expected, even if the incident recurs.

• Brand Name: ARTIS Q CEILING
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1 or; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1 or; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 15379424
• Report Number: 3004977335-2022-42734
• Device Sequence Number: 5506199
• Product Code: OWB
• UDI-Device Identifier: 04056869009988
• UDI-Public: 04056869009988
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K181407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2022

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: 08/31/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 11/11/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown