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

Model Number 11327600

Device Problem Poor Quality Image (1408)

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

Event Date 11/26/2023

Event Type  malfunction  

Event Description

Siemens became aware of a malfunction that occurred while operating the artis icono biplane system.During an emergency procedure, the system stopped in the middle of acquisition and the whole screen pixelated.The system went into bypass mode.After the unit was rebooted, the screen remained pixelated when acquiring an image.The patient had to be moved, and the procedure was completed on an alternate unit.We have no indications of any adverse effects on the health status of the involved patient.

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported event.A supplement report will be filed if additional information becomes available.

Manufacturer Narrative

The investigation of the reported event showed that the functional insulation on the inverter printed circuit board (pcb) was damaged.This caused permanent short circuit, which was detected by the generator¿s fault monitoring system, causing x-ray release to disable.The log files show that all x-ray release attempts were aborted, and a message was displayed to the user for each occurrence.Siemens is not aware of any similar occurrences in the field.The inverter pcb was exchanged by customer service engineer, and the issue was resolved.The occurrence rate of the identified cause has been checked and no error accumulation has been identified.The occurrence rate is below the defined threshold.

• Brand Name: ARTIS ICONO BIPLANE
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 18229802
• MDR Text Key: 329270065
• Report Number: 3004977335-2023-00156
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869063317
• UDI-Public: 04056869063317
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K193326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1