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

Model Number	11327700
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of the reported incident showed that the patient had not been strapped during the procedure.When the medical professional leaned on the patient, the patient fell to the floor and sustained minor injuries.No serious adverse effects to the health of the patient were communicated.The instructions for use describe the possibility of patient fall as well as means to prevent a fall.The user is instructed to never leave a patient unattended on the tabletop, to use the provided accessories such as the immobilizing straps to secure patient in a stable position, and to always keep the mattress fixed on the tabletop with the velcro.The customer has been made aware of the importance of strapping the patient to the table to prevent similar occurrences.The occurrence rate of the 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.
Event or Problem Description
Siemens became aware of an incident that occurred on the artis icono floor system.The reported event occurred during a patient examination.A carbon armrest provided by siemens was placed between the tabletop and the mattress.According to the information provided by the user, the patient was not strapped to the tabletop and seemed to be agitated.As a result, the patient fell off the table.We have no indications of any serious adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
The user was advised to use straps when patients appear agitated.It was confirmed that the customer ordered additional straps.Siemens is conducting a thorough investigation of the reported event.A supplement report will be filed upon completion of the investigation.

• Brand Name: ARTIS ICONO FLOOR
• 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; siemenstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 19062678
• Report Number: 3004977335-2024-00039
• Device Sequence Number: 5897214
• Product Code: OWB
• UDI-Device Identifier: 04056869149325
• UDI-Public: 4056869149325
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K193326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 11327700
• 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: 03/26/2024
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 05/07/2024
• 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: Unknown