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

Model Number 10093962

Device Problems Mechanical Problem (1384); Unintended Collision (1429)

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

Event Date 01/31/2022

Event Type  malfunction  

Manufacturer Narrative

With current information it cannot be excluded that in worst case a minor to serious injury might be an outcome if the user had continued to use the system, and the table would have tilted uncontrollably or would have detached from the system due to the damage to the tilting mechanism caused by a collision with a foreign 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).

Event Description

Siemens local service engineer was dispatched to inspect the axiom iconos r200 unit for making noises.The engineer discovered that the system had collided with an unknown object resulting in multiple damages.Provided pictures showed damage to the system including damage to a bearing for the tilt mechanism.There are no injuries attributed to this event.The reported event occurred in (b)(6).

Event Description

Siemens local service engineer was dispatched to inspect the axiom iconos r200 unit for making noises.The engineer discovered that the system had collided with an unknown object resulting in multiple damages.Provided pictures showed damage to the system including damage to a bearing for the tilt mechanism.There are no injuries attributed to this event.The reported event occurred in (b)(6).

Manufacturer Narrative

With current information it cannot be excluded that in worst case a minor to serious injury might be an outcome if the user had continued to use the system, and the table would have tilted uncontrollably or would have detached from the system due to the damage to the tilting mechanism caused by a collision with a foreign 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 initial mfr report # should have been reported as 3004977335-2022-15039 since the event occurred in 2022.For supplemental reporting purposes, the mfr report # 3004977335-2021-15039 was used so it can be linked to the initial report.Additional information: d4: udi was added.H8: usage of device added.H3,h7, h8 populated.The reported event was investigated in detail.The investigation by service technician at customer site showed that the stand had sustained a collision and two covers were damaged.Furthermore, the table base was bent with its roller out of its position.Some noise from the table bases could be heard.The analysis of the provided log files did not indicate any malfunction of system movements which may have caused the fault.If a released button or joystick is recognized during initialization, the function is blocked, and an error is stored in the error log file.There were no entries found in the log file indicating this misbehavior.The provided images showed the damage to the iconos r200 was caused by massive external force resulting in the damaged parts of the system.This happened when the system collided with an external metallic object (patient stair step) during system movement under operator control.This was also confirmed by the service technician.Due to the deformations on the system, a secure usage of the system is no longer guaranteed.Based on the available information and the investigation results a system malfunction could not be determined.The system worked as specified.It is in the responsibility of the operator to make sure that there are no objects in the way when the system is moved.In the system operator manual, axd3-340.620.14.01.02, it is stated that the user must pay attention while moving the system.It was strictly recommended not to use the system until repairs could be completed.According to the received information, the described issue was resolved at customer site by the service technician with the replacement of the affected parts, especially regarding possible consequential damage that was not visible in the photos.The complaint was closed with this statement and without further measures.Internal id# (b)(4).

• 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: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 13497438
• MDR Text Key: 285924250
• Report Number: 3004977335-2021-15039
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: PE
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other