MAUDE Adverse Event Report: SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. ARTIS ONE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10848600

Device Problems Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)

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

Event Date 08/28/2020

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 artis one system.During a cardiology procedure, the user reported that the monitor display in the exam room started to blink (image appearing and disappearing).The user restarted the system ,but couldn't fix the problem.The patient was transferred to another system in the same hospital, and finished the procedure successfully.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 error.The investigation was performed considering complaint description, cs reports, system history and system log files.The investigation showed that the cause of the error was due to a graphic card defect.According to information from field, during s cardiology procedure the monitor display in the exam room started to blink (image appearing and disappearing).The customer attempted to restart the system but couldn't fix the problem.The customer service engineer (cse) on site checked and replaced the graphic card of the smart pc.After the hardware exchange, the system recovered and works as specified.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: ARTIS ONE
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.; gaoxin c ave.; 2nd, hi-tech industrial park; shenzhen, china 51805 7; CH 518057
• MDR Report Key: 10534046
• MDR Text Key: 206966059
• Report Number: 3004754211-2020-44310
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869009964
• UDI-Public: 04056869009964
• Combination Product (y/n): N
• PMA/PMN Number: K133580
• 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: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10848600
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1