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

Model Number	10848281
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware of an incident that occurred while operating the artis q ceiling unit.Information was provided that a patient fell off the table and suffered a minor injury to the head.The patient was kept at the facility for observation and was reported to be doing well.No other issues have been reported.Siemens has requested additional information about this event.
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 of the reported incident was completed by our experts.It was confirmed that the patient suffered a small swelling (2 cm) as a result of the fall.No long-term health consequences were reported.The detailed log-file investigation showed no indication for a system malfunction for the time of the event.In general, tabletops are not designed to prevent patient fall due to required flexibilities for the users.Appropriate material is provided with the system for patient fixation as described in the instructions for use.Additional accessories, e.G.For the treatment of heavy patients and depending on the application of other supporting material, are offered.However, fixation by means of a belt/body straps is essential.The entire process of patient immobilization is the responsibility of the operator.This includes the tabletop, the mattress, the fixation accessories, the alignment of the material and the patient on the table, and the proper execution of the fixation by the operator, including appropriate attention to the patient, e.G., depending on the patient's responsiveness.The concerned artis q ceiling system did not cause or contribute to the patient's fall.

• 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: 18885964
• Report Number: 3004977335-2024-00030
• Device Sequence Number: 3088973
• Product Code: OWB
• UDI-Device Identifier: 04056869009988
• UDI-Public: 04056869009988
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 03/08/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 04/15/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male