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

Model Number 10094141

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2021

Event Type  malfunction  

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 a malfunction occurred while operating the artis zee biplane system.During an interventional procedure, the user reported a problem setting up 3d.The procedure was continued and completed on an alternate system.We are unaware of any impact to the state of health of the patient involved.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

The investigation was completed by our experts.A potentiometer is responsible to provide information about system positions.The investigation of the provided log files showed that the system had detected a mismatch of information from two sensors (potentiometer and encoder).Consequently, the system changed its mode to the "reduced stand/table speed" and displayed this message to the user.The reduced speed mentioned above is a mitigation for such cases; it is described accordingly in the instruction for use (ifu)'.It is to be noted that the x-ray functionality was still available to the operator as wells as table movements with reduced speed while using the override mode.Upon investigation the involved siemens local service engineer checked the system and found a defect in the potentiometer.The cause of the defective potentiometer could not be determined.Following the hardware replacement, there were no further issues identified.Thus, the hardware issue was determined as the relevant root cause.

• Brand Name: ARTIS ZEE BIPLANE
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 12074848
• MDR Text Key: 258646002
• Report Number: 3004977335-2021-85014
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869010069
• UDI-Public: 04056869010069
• Combination Product (y/n): N
• PMA/PMN Number: K181407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10094141
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1