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

Model Number	10094135
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.A supplement report will be filed if additional information becomes available.H6 - c-arm.
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the artis zee floor unit.During a percutaneous coronary intervention, the c-arm lost all movement.The patient was moved, and the procedure was completed on an alternate unit.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
The investigation of the reported event was completed by our experts.The analysis of the log files showed that the joystick was deflected without the deadman grip (dmg) being active.For safety reasons, c-arm movements are not possible by simply deflecting the joystick.However, it was still possible to rotate/angulate the c-arm using the membrane buttons on the flat-panel detector.The onsite service intervention revealed that the dmg was defective.To resolve the problem, the control module was exchanged as part of service activity.A detailed analysis of the defective part showed that liquids had penetrated the joystick housing.It is assumed that this occurred when the user cleaned/disinfected the system.The operator manual and cleaning guide contain adequate information and instructions to prevent liquids from entering the system.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.The incident described in the adverse event is not classified as a reportable event after a thorough investigation because neither serious injury, death, nor unexpected prolonged hospitalization of the patient or other person occurred or is to be expected, even if the incident recurs.
Additional Manufacturer Narrative
7/18/2024: supplemental mdr 2 was submitted to the fda for correction of the model number and the primary udi number in section d4.

• Brand Name: ARTIS ZEE FLOOR
• 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: 18005936
• Report Number: 3004977335-2023-00138
• Device Sequence Number: 18037883
• Product Code: OWB
• UDI-Device Identifier: 04056869010045
• UDI-Public: (01)04056869010045(21)138440
• 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,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: 10094135
• 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: 10/05/2023
• Supplement Date Received by Manufacturer: 01/29/2024; 07/18/2024
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 01/29/2024; 07/18/2024
• 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
• Patient Sex: Unknown