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

Model Number 11327600

Device Problems Loss of Data (2903); Radiation Output Failure (4027)

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

Event Date 07/28/2023

Event Type  malfunction  

Event Description

Siemens became aware of a malfunction while operating the artis icono biplane system.During an emergency patient procedure, the system went into a bypass mode.This resulted in a long-term procedure delay.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.As this event is under investigation yet been determined.A supplement report will be filed if additional information becomes available.

Manufacturer Narrative

The investigation of the reported issue was performed by our experts.Analysis of the log files showed that system was in normal mode at the time of the issue occurrence but acquisitions were not possible.The cause was full image disc with not enough space to create an image file, which resulted in acquisitions not being saved.As the imaging system is not an archiving system, periodic deletion of old patient data is required to avoid full memory.The message "memory full, delete patients" was displayed to the user.The instructions for use provide adequate guidance in the event of this message.Furthermore, database usage status can be checked on the user interface to prevent the database from getting full.The affected system has been checked and no system failure is identified.To resolve the problem, old patient data was transferred to an external drive and then deleted on the imaging system.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.

• Brand Name: ARTIS ICONO BIPLANE
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 or; rittigfe;d 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 4843234197
• MDR Report Key: 17543545
• MDR Text Key: 321266604
• Report Number: 3004977335-2023-00090
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869063317
• UDI-Public: 04056869063317
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• 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: 10/09/2023
• 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