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

Model Number	10280959
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	01/14/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the artis zeego system.The customer reported no image on the large display after system start up.Further information was provided that the patient passed away.At this time, there is no causal relationship between the death of the patient and the system behavior.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 events.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.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware error.The investigation was performed considering complaint description, cs reports, system history, and system log files.According to log file analysis the system was running and in working order on the morning of (b)(6) 2022.After a restart of the system, which was conducted before the start of the procedure, the system came up in bypass fluoro mode and no image was displayed on the main display.After about 3 hours the customer tried to resolve the issue by restarting the system, however as no power cycle was performed, the system remained in bypass mode.After another hour the user performed a power cycle of the system.Afterwards, the system recovered and was in working order.Corresponding descriptions can be found in the instruction for use (ifu) of the respective system under the chapter "troubleshooting" for handling this kind of failure scenario.For this specific scenario the user is advised to restart the system or perform a power cycle.Upon investigation the involved customer service engineer (cse) checked the system, analyzed the log files as well as troubleshooting.A defective power supply unit of the mdm was identified.The mdm problem could be confirmed in the log file analysis.After exchange of the mdm (multi display manager) the problem did not reoccur.The spare parts consumption was checked and a possible general fault that would require corrective measures of the installed base could not be determined by the investigation.According to a statement provided by the physician of the hospital, a causal relationship between the issue and the patient's death is improbable.Furthermore, the investigation could not show a direct causal relationship between the patient's death and the issue of the system.

• Brand Name: ARTIS ZEEGO
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 13333216
• Report Number: 3004977335-2022-13311
• Device Sequence Number: 1646474
• Product Code: OWB
• UDI-Device Identifier: 04056869010083
• UDI-Public: 04056869010083
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K181407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Inspection,Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 10280959
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 04/07/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown