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

Model Number 10848282

Device Problems No Display/Image (1183); Loss of Data (2903)

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

Event Date 02/10/2023

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported event.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed if additional information becomes available.

Event Description

It was reported to siemens that a malfunction occurred while operating the artis q biplane system.During an emergency patient procedure, an error occurred.The images were not saved or transferred to the workstation following the acquisitions.The patient had to be relocated and the procedure was completed on an alternate unit.We have no indications of any adverse effects on the health status of the involved persons.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

H10: manufacturer narrative: siemens healthiness completed the investigation of the reported event.The investigation was performed based on expert discussions, consideration of the complaint description, customer service reports, system history, and system log files.According to the provided information, during an emergency procedure (for a cerebral embolization) an error occurred.The system acquired images seen on screen failed to save.The case was abandoned, and patient transferred to another hospital for treatment.No health consequences were reported to this event.Detailed investigation of the log files revealed that a dicom storage error has occurred in data management component.System was in normal mode at the time of event as this issue will not cause any crash to the sw.During x-ray, images will be displayed both in exam and control room monitors.But storage into local database would fail.Because of this storage failure, image transfer was not initialized to syngo x workplace (xwp).A system restart was performed by user which did not solve the issue.The issue was finally resolved by recreation of database as part of service activity.A software issue is determined as root cause which could result in rare cases in the seen behavior.Basic system functionalities (x-ray, system movements) were available all the time, so that the procedure could be finished or stopped in a controlled manner if required.In this case, the procedure was continued with an alternative system.The occurrence rate of the aforementioned error pattern was checked.A possible error accumulation or even a systematic error, which leads to a corrective action of the installed base, could not be determined by the investigation.

• Brand Name: ARTIS Q 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 HEALTHCARE GMBH-AT; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 17010417
• MDR Text Key: 316291692
• Report Number: 3004977335-2023-00030
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K181407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10848282
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1