MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AXIOM ICONOS R200; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number 10093962

Device Problems Use of Device Problem (1670); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2020

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.Internal id # (b)(4).

Event Description

It was reported to siemens that a crack in the rear frame of the rail for the tube stand and a dent in the rail of the axiom iconos r200 system was found.There is no patient involvement in this case.No injuries are attributed to this event.The reported event occurred in (b)(6).

Manufacturer Narrative

The issue was investigated in detail.According to the received information, a crack was found in the rear frame of the base and the rear rail was bent.The provided images showed a breach in the metal guiding rail for the rear bearings of the column.The concerned system at the customer site was replaced with a luminos drf max.Since the unit was immediately scrapped following the replacement, the defective table strut was no longer available for a detailed analysis and a reasonable measurement of tolerances was not possible.Therefore, a simulation with a finite element method (fem) analysis was performed with the worst-case scenario (eccentric bearings adjusted to the maximum).This simulation showed that if the eccentric bearings are overly adjusted, the guiding rail of the strut gets overloaded and can break over the time.This could lead to the described issue.Risk potential of the damaged strut was performed as well.A floating bearing (e.G.In the breached guiding rail) only contributes to a small extent to the guidance.The main load is borne by the linear guide and the drive chain.The floating bearing is needed to meet the requirements for central beam migration at + 90 ° /-90 °.Such hazard situation could never occur.Based on the results of the fem analysis a sample of 20 new table struts were checked for correct dimensions and parallelism of the guiding rails.It could be confirmed that the tolerances of the guiding rails are all below the determined acceptable limit of the fem analysis.To check the negative effect of a cracked guide to the function of the system over a longer period, an endurance test was carried out with the worst-case settings.This endurance test (approx.9.500 cycles corresponding to approx.1.5 years of operation) did not show any problems in the system functionality.Also, the central beam deviation (tube to detector) was only about 1mm compared to the situation before.The investigation results showed that the crack was most likely caused either by high mechanical load at the rail or by wrongly adjusted bearings and/ or guide rails not being parallel.The exact root cause could not be determined since the affected complaint part was no longer available.However, the investigation also showed that there are no safety relevant risks.It could also be confirmed that there is no risk of falling parts.

• Brand Name: AXIOM ICONOS R200
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10194612
• MDR Text Key: 220726586
• Report Number: 3004977335-2020-34396
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• PMA/PMN Number: K992660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10093962
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 06/25/2020
• Supplement Dates Manufacturer Received: 01/19/2021
• Supplement Dates FDA Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other