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

Model Number	11327700
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reporting facility did not provide a contact name.The reporting facility phone number is: (b)(6).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.
Event or Problem Description
It was reported to siemens that a malfunction occurred when using the artis icono floor system.The registered name changed during the patient examination.The patient name changed to a different name resulting in some images being filed under the wrong patient.The issue was recognized by the customer and was corrected before the images were sent to picture archiving and communication system (pacs).Siemens is unaware of any adverse effect to the patient's health due to this issue.Detailed clarification of the event are being investigated, therefore, this report is being submitted with an abundance of caution.The reported event occurred in (b)(6).
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be a user error.According to the investigation, the customer was examining a patient with the artis icono floor and the system was functioning properly.Before the examination was completed, a second patient, from the previous friday, was reopened from the sensis (different, data-linked system).Unfortunately, the operator working at the artis icono floor did not notice this at first and mistakenly continued his examination in the second opened patient.When he realized that he had finished the examination in the wrong patient, he initially thought that it was a system error, however, this was not the case.Both the service intervention on site and the detailed examination at the factory were able to clarify the facts.Our customer service team has already provided the customer with the necessary information and instructions on site to prevent such problems from occurring in the future.A possible malfunction of the system could not be determined by the examination.The system works as specified.After detailed investigation, the incident is not classified as a reportable event as neither serious injury, death nor an unexpected, prolonged hospitalization of the patient or any other person occurred or could be expected.

• Brand Name: ARTIS ICONO FLOOR
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH - AT; siemensstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 11146131
• Report Number: 3004977335-2021-61112
• Device Sequence Number: 715827
• Product Code: OWB
• UDI-Device Identifier: 04056869149325
• UDI-Public: 04056869149325
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K193326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2021

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: 11327700
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1