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

Model Number	10094135
Medical Device Problem Codes	Mechanical Jam (2983); Output Problem (3005); Radiation Output Failure (4027)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the artis zee floor system.During an emergency procedure, the user reported that stand movement was not possible.It was later reported that the patient passed away.Siemens has requested additional information in order to conduct an investigation of the reported event.
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.
Event or Problem Description
According to the available information, an emergency patient with a cerebral infarction was treated.During the procedure, system movements were impaired.However, the procedure was successfully completed.The patient then passed away the next day because of an acute myocardial infarction.There is no indication that the patient¿s outcome is related to the impaired system movements.
Additional Manufacturer Narrative
The investigation was performed by experts considering complaint description, cs reports, system history, system log files.The onsite service intervention revealed that one of the 4 springs of the collimator's proximity switch was loose.As a result, the collision protection guard of the collimator was active and normal system movements (normal speed, autodrive) were not possible.In this condition, system movement are still possible with reduced speed in override mode.The override mode is a mitigation for this kind of failure scenario, so that a procedure can be aborted in a controlled manner if needed.The instruction for use contains adequate instruction for this kind of scenarios and how to move the system with override mode.Due to the system design, the system movement stops regardless of whether a collision sensor becomes active or inactive.In this particular case, the collision sensor was constantly switching/toggling back and forth between active and inactive status in the range of seconds.As a result, system movements were also stopped in override mode, so that the possibility of system movements was severely impaired.To solve the problem, the loose spring has been reinstalled and secured as part of the service activity.This is the first reported case with this error sequence.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 ZEE 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; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: marion mints ; 40 liberty blvd; malvern, PA 19355 ; 4843231632
• MDR Report Key: 20438045
• Report Number: 3004977335-2024-00119
• Device Sequence Number: 7990966
• Product Code: OWB
• UDI-Device Identifier: 04056869010045
• UDI-Public: (01)04056869010045
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10094135
• Device Catalogue Number: 10094135
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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