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

Model Number	10280959
Medical Device Problem Codes	Use of Device Problem (1670); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware of a malfunction that occurred on the artis zeego unit.During an emergency patient procedure, the automatic robot drive could not be activated restricting table motion.The patient had to be relocated, and the procedure was completed on an alternate unit.Siemens is unaware of any adverse health impact to the state of health of the patient involved.
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
Detailed investigation of the reported event showed that the customer activated manual table rotation several times but did not rotate the table to the necessary position of 0 degrees.This is a requisite for achieving the desired selected system position ¿left side¿.No system malfunction could be identified.The system displayed appropriate instructions to be performed by the user prior to system usage.The system behaved according to the specifications.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 ZEEGO
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 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: 19828643
• Report Number: 3004977335-2024-00088
• Device Sequence Number: 15491436
• Product Code: OWB
• UDI-Device Identifier: 04056869010083
• UDI-Public: (01)04056869010083
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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: 10280959
• 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: 07/10/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown