MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH-AT ARTIS Q.ZEN BIPLANE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10848355
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	12/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the artis q biplane system.The customer reported having problems moving the table and gantry during cpr.Additional information was provided that the patient resuscitation failed and 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 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
The failure occurred on the artis q.Zen biplane and not on the artis q biplane as previously stated, therefore changes made in this report are: udi device id: (b)(4).Medical device name: artis q.Zen biplane.Model: 10848355.Serial number:(b)(6).
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be software error.A detailed investigation revealed that normal system movement was blocked due to a software issue.The error message "limited stand/table movement, sc" was displayed.As a result, movement of the system was only possible in "override mode" at reduced speed.The operator manual contains adequate instructions for the safe operation of the system in this failure scenario.In addition, our x-ray system is equipped with a separate patient rescue function in case of emergency, as in the present case, which allows mechanical unlocking of the motorized system.The c-arm/stand can then be moved by hand to allow better access to the patient.Independent of the c-arm/stand, the patient table also has such a function.Both functions are described in detail in the instructions for use.According to the customer, the restriction of movement of the system only slightly complicated the effort on site.Furthermore, consultation with the customer revealed that our system did not contribute to the patient's death, but that the patient died due to the underlying disease.In this regard, the investigation revealed that the temporary malfunction of the system did not result in an increased hazard potential.By switching off and on again (power cycle reset), the system could be put back into operation.The original error pattern which led to the reported slow movement could not be reproduced during the on-site intervention.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.After detailed investigation, the incident is not classified as a reportable event as neither serious injury, death nor an unexpected, prolonged hospitalization of the patient or any other person occurred or could be expected.

• Brand Name: ARTIS Q.ZEN BIPLANE
• 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 ; 6104486461
• MDR Report Key: 13017823
• Report Number: 3004977335-2021-09545
• Device Sequence Number: 14689672
• Product Code: OWB
• UDI-Device Identifier: 04056869009995
• UDI-Public: 04056869009995
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Repair,Inspection
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2021

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: 10848355
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2021
• Supplement Date Received by Manufacturer: 01/04/2022; 02/07/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 01/04/2022; 02/07/2022
• 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