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

Model Number 10094135

Device Problem Mechanical Problem (1384)

Patient Problems Dyspnea (1816); Unspecified Heart Problem (4454)

Event Date 06/30/2022

Event Type  Death  

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.Internal id # (b)(4).

Event Description

It was reported to siemens that a malfunction occurred while operating the artis zee floor system.During a surgery table movement was no longer possible.The patient with cardiac issues and shortness of breath passed away in the or.According to the user, siemens device did not contribute to the patient's death.The device was operational following the incident.Siemens has requested additional information in order to conduct an investigation of the reported event.The reported event occurred in germany.

Manufacturer Narrative

On (b)(6) 2022, during an interventional procedure, a patient with cardiac issues and shortness of breath passed away.According to the complaint description, during surgery the table movement was no longer possible.An onsite service examination by the local technician did not reveal any system deficiencies.All axles of the table were checked, and no failure was found.Further log file analysis revealed that at approximately 10:50 the user activated the floating tabletop (feature to easily move the table in longitudinal and transversal direction) and the table was moved longitudinally.At approximately 11:03 the table was tilted longitudinal.When the table is tilted in this way, longitudinal movement of the table is not possible with the floating tabletop function, as the table would drift independently due to gravity, as described in the system instruction for use.At approximately 11:06 the table tilt position detector detects a lot of very small movements (up to 0.08°) of the table tilt.This clearly indicates that a cardiopulmonary resuscitation (cpr) was performed at this time.The investigation did not reveal any malfunction or deterioration in the characteristics or performance of the system.Since there was no malfunction of the system, the system did not contribute causally to the patient situation.The functions of the table movement, especially when tilting the table, were discussed and demonstrated by siemens together with the user at the patient table.The problem reported by the customer could not be confirmed after a thorough investigation.The system works as specified.The incident, described in the adverse event, is not classified as a reportable event after a thorough investigation because no malfunction of the system could be detected.Internal id # (b)(6).

• Brand Name: ARTIS ZEE FLOOR
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH - AT; siemensstr. 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 14931795
• MDR Text Key: 295355138
• Report Number: 3004977335-2022-34548
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869010045
• UDI-Public: 04056869010045
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K181407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10094135
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death