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

Model Number	10849000
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware of an adverse event that occurred while operating the artis pheno system.Prior to the procedure during the patient transfer, the patient fell off the table.Additional information was received that the patient was transferred to the emergency room.The details of the incident are unclear; siemens has requested additional information regarding this event.
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 if additional information becomes available.
Additional Manufacturer Narrative
The reported issue was analyzed by our experts and the following conclusions were made.The reported event was attributed to an unexpected rotation of the table during the transfer process.Siemens local service engineer inspected the concerned unit and discovered that the table's rotation brake was loose, which meant that the table rotation was not properly restricted.However, the exact cause for the loose brake could not be determined.As part of the service activity, the engineer adjusted and tightened the table's rotation brake, restoring the system to its proper working order.It is user¿s responsibility to ensure that the table is securely immobilized and cannot move prior initiating any patient transfer.This precaution is essential to guarantee the safety and stability of the patient throughout the transfer process.The operator manual contains adequate instructions about patient transfer protocols and safety measures.Relevant warnings are outlined within the chapter titled "transferring and positioning the patient." (see operator manual excerpts below).¿warning: patient transfer - the patient may fall to the ground.- move system into patient transfer position.- park the patient stretcher/bed right alongside the patient table without a gap.- lock the brakes of patient stretcher/bed.- always keep the mattress fixed on the tabletop with the velcro.- press the block movement button to prevent motorized movements or temporarily remove the consoles.- prevent pushing the table transversally with excessive force during patient transfer or hold it if it cannot be avoided.- use positioning aids for moving the patient.¿ the occurrence rate of the identified cause has been checked and no error accumulation has been identified.The occurrence rate is below the defined threshold.Section h6 code g07001 - table brakes.

• Brand Name: ARTIS PHENO
• 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; forccheim 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 21035435
• Report Number: 3004977335-2024-00161
• Device Sequence Number: 7595856
• Product Code: OWB
• UDI-Device Identifier: 04056869046877
• UDI-Public: (01)04056869046877
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K241572
• 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): 02/05/2025

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
• Device Model Number: 10849000
• 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: 12/23/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 02/05/2025
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Female