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

Model Number 10094135

Device Problem Mechanical Problem (1384)

Patient Problem Cardiac Arrest (1762)

Event Date 12/27/2020

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.

Event Description

It was reported to siemens that an adverse event occurred while operating the artis zee floor system.During an interventional procedure, the user reported that the stand would not move at all and the system went down.It was later reported that the patient was admitted in a critical condition and passed away as the result of a pulmonary embolism.At this time there is no causal relationship between the patient condition and the system malfunction.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware error.The cause of the fault was a defective potentiometer.The potentiometer was replaced on site and the system again functioned as specified.The problem described has not been reported again.The spare parts consumption of the affected component was checked and a possible general error that would require corrective actions of the installed base could not be determined by the investigation.According to the information available, the patient was already in a critical state when he arrived at the hospital.After consultation with the physicians, no causal connection between the above-mentioned malfunction and the patient's passing can be identified.

• Brand Name: ARTIS ZEE FLOOR
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 11200699
• MDR Text Key: 227723273
• Report Number: 3004977335-2021-62451
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869010045
• UDI-Public: 04056869010045
• Combination Product (y/n): N
• PMA/PMN Number: K181407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10094135
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death