MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH- AT AXIOM ARTIS DTA; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 7008605

Device Problem Connection Problem (2900)

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

Event Date 02/11/2021

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 axiom artis dta system.During an emergency procedure, the user reported a "no connection" message on the data display and 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 data communication problem.During investigation, it was determined that the ethernet switch of the network had a defect.Unfortunately, the network switch was disposed of by the customer, and it was not available for further investigation.Based on the available information, the on-site technician as well as the technical specialists agree that the defective ethernet switch was the cause of the problem.This thesis is also supported by the fact that after replacing the component, the system worked as specified and the original error has not been reported again.A possible general error that would require corrective measures 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: AXIOM ARTIS DTA
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 11342146
• MDR Text Key: 232640508
• Report Number: 3004977335-2021-68006
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K052202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7008605
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1