MAUDE Adverse Event Report: SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD. AXIOM ARTIS U; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10094012

Device Problems Defective Component (2292); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/24/2018

Event Type  malfunction  

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware defect.Investigation was performed considering complaint description, cs reports, system log files and system history.The pc was delivered together with the system in 2011.Investigation by the supplier showed that both the main board and the vga graphics card were defective.A siemens customer service engineer replaced the pc and brought the system back into specification.Following the repair, no further complaints have been reported.There is no negative awareness in regards to the quality and performance of the affected component as the spare part consumption rate is below threshold.The manufacturer will initiate an update to the maintenance instructions in order to enhance the inspection of the flc and to decrease the potential for failure in the future.

Event Description

It was reported to siemens that a malfunction occurred while operating the axiom artis u system.During an arterial embolization procedure, the user reported that the flc automatically began to reboot.After the reboot the flc load failed and resulted in a delay in procedure of approximately twenty minutes.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.

• Brand Name: AXIOM ARTIS U
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD.; 278 zhou zhu road; shanghai, china 20131 8; CH 201318
• Manufacturer (Section G): SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD.; 278 zhou zhu road; shanghai, china 20131 8; CH 201318
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 8514159
• MDR Text Key: 146379948
• Report Number: 3003202425-2019-62711
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K040675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10094012
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1