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

Model Number 7008605

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

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

Event Date 09/07/2020

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 interventional procedure, the user reported that no images were displayed after x-ray acquisition.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 issue.The investigation showed that the error was caused by an image system issue.The file system of the image system computer (rt-pc) went corrupt leading to the error.If such an error occurs, the designed mitigation is to switch to "bypass fluoro mode".When the imaging system is not available, as in the given case, the system enters this mode where only continuous fluoroscopy with compromised image quality is available and the acquired scenes cannot be saved and reviewed.Normal system functionality can be restored only after local service intervention.The service engineer went onsite and restored the data base which corrected the file system and eliminated the error.Afterwards, the system was returned to operation and the issue has not been reported again.A general error which would require corrective action 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: 10553562
• MDR Text Key: 207560759
• Report Number: 3004977335-2020-45533
• 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: Repair
• Type of Report: Initial,Followup
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• 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: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1