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

Model Number	10848283
Medical Device Problem Code	Unintended Collision (1429)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware of an incident that occurred while operating the artis q zeego system.It was reported that the c-arm crashed into the stand.We have no indications of any adverse effects on the health status of the involved persons.
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.A supplemental report will be filed if additional information becomes available.
Additional Manufacturer Narrative
H3, h6: the detailed investigation of the complaint event and system was completed.The investigation was performed based on expert discussions considering the complaint description, customer service reports, system history, system log files, and event simulation.According to the initially communicated information, after a procedure, the c-arm moved into the collision area of the stand link arm during the operator-controlled system movement but did not slow down as specified.In this case, the c-arm hit the cover of the stand link arm and as a result, the cover was damaged.The damaged cover was exchanged as part of service activity.Detailed investigation of the log files showed that the problem of movement speed not slowing down was due to a software (sw) error.In rare cases, under special boundary conditions, this error can cause a communication problem that could lead to the system behavior seen.This sw issue will be fixed with the upcoming sw patch.Risk control measures such as proximity switches and dead man's grip remain functional in this fault scenario.In general, it is in the responsibility of the operator to check for potential collisions before releasing system motions.The operator manual contains adequate instructions about system movement and how the operator can avoid a collision.
Additional Manufacturer Narrative
7/18/2024: supplemental mdr 2 was submitted to the fda for correction of the primary udi number in section d4.

• Brand Name: ARTIS Q ZEEGO
• 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 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: 18160761
• Report Number: 3004977335-2023-00153
• Device Sequence Number: 7215998
• Product Code: OWB
• UDI-Device Identifier: 04056869010007
• UDI-Public: (01)04056869010007(21)117133
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2024

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: 10848283
• 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: 11/03/2023
• Supplement Date Received by Manufacturer: 12/26/2023; 07/18/2024
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 12/26/2023; 07/18/2024
• 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