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

Model Number 7152478

Device Problems Material Deformation (2976); Material Integrity Problem (2978); Material Twisted/Bent (2981)

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

Event Date 12/08/2021

Event Type  malfunction  

Event Description

A damaged footrest on the axiom iconos r200 was reported to siemens.A provided picture showed that the footrest was bent on one side and, therefore, could not be correctly attached to the rail of the patient table.No injury was communicated in this case.Siemens requested more information to proceed with the investigation.The reported event occurred in (b)(6).

Manufacturer Narrative

With currently available information it cannot be excluded that in worst case a minor to serious injury might be an outcome if the user continue to use the system and the footrest gets detached while a patient is standing on it.It is currently assumed that the damage was caused by a collision of system parts with an external object.Siemens is conducting a thorough investigation of the reported event.A supplement report will be filed upon completion of the investigation.Internal id # (b)(4).

Manufacturer Narrative

The issue was investigated in detail.The investigation of the provided photos showed that the damage to the footrest had been caused by a massive external force.This can occur, for example, if the footrest collides with an obstacle located under the footrest during the table movement.Due to the deformations on the footrest, a secure attachment of the footrest to the wall-side rail of the tabletop was no longer possible.Therefore, the footrest should have not been used until replacement due to increased risk of the footrest becoming detached.For a detailed root cause analysis, the affected footrest was requested.According to information received, the customer refused price quote for replacement.Therefore, the affected part was not available for investigation and no further analysis could be performed.The spare part consumption of the concerned part footrest (7094613) shows values that are below the defined threshold.No general problem is known.Based on the available data and information the damage was most likely caused by a collision of the footrest with an external object performed by the operator, which led to an excessive force acting on the damaged part.According to the information from the service technician, no signs of collision could be found.It is the responsibility of the operator to make sure that there are no objects in the way when the system is moved.This is also described in the operator manual axd3-340.620.14.01.02 (page 30/ 38).It was strongly recommended to the suer not to use the footrest as it may detach during use and cause patient to fall during system movement.

• 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
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 12975926
• MDR Text Key: 285826333
• Report Number: 3004977335-2021-08485
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K992660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/10/2021

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: 7152478
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/10/2021
• Supplement Dates Manufacturer Received: 04/04/2022
• Supplement Dates FDA Received: 04/08/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other