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

Model Number	10848280
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens became aware of an incident that occurred with the artis q floor system.The customer uses the narrow tabletop configuration with the artis q floor system.To increase the width of the table for larger patients, plexiglass panels are used under the system mattress.These plexiglass panels were sourced by the customer internally and are not approved/provided by siemens.During patient transfer to the table with no system movement, a staff member caught her hand against this plexiglass, fracturing a finger.
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported events.A supplement report will be filed upon completion of the investigation.
Additional Manufacturer Narrative
H3, h6: the investigation was performed on expert discussions considering complaint description, customer service reports, and system history.Based on available information, at the beginning of a procedure during patient transfer of the patient from the transport bed to the table without moving the system, a staff member caught his hand on plexiglass and fractured his finger.The facility uses internally sourced plexiglass panels under the artis mattress to increase the width of the table for larger patients.No system deficiency could be determined.System worked as intended.The operator manual contains adequate information concerning the use of the system with unauthorized equipment/ accessory.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.

• 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: 17469400
• Report Number: 3004977335-2023-00078
• Device Sequence Number: 18015687
• Product Code: OWB
• UDI-Device Identifier: 04056869009971
• UDI-Public: 04056869009971
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: 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?: Yes
• Is this a Product Problem Report?: No
• 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: 07/18/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 10/02/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female