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

Model Number 11327600

Device Problem Mechanical Problem (1384)

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

Event Date 04/28/2021

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 icono biplane system.During an emergency procedure, the user reported that no system movements were possible.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

Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware error.The initial report assumed that no movement of the robot was possible, however, this did not affect the complete system as investigated.According to the log files, system movement at slow speed was possible with the exception of the affected swivel axis of level a of the biplane system.The system behavior was caused by a defective encoder cable which was proven by testing the replaced and returned part.The affected encoder cable was replaced by the local service organization and the error has not been reported again.A general problem can be ruled out as this would have been noticed during the final inspection at the factory and during the final tests on site.The spare parts consumption of the encoder cable was checked and any accumulation of faults or even a possible general fault that would require correction 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 ICONO 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: 11775884
• MDR Text Key: 249065383
• Report Number: 3004977335-2021-78551
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869063317
• UDI-Public: 04056869063317
• Combination Product (y/n): N
• PMA/PMN Number: K193326
• 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: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11327600
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/05/2021
• Supplement Dates Manufacturer Received: 07/08/2021
• Supplement Dates FDA Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1