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

Model Number 10093962

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 11/18/2021

Event Type  malfunction  

Manufacturer Narrative

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).

Event Description

Siemens local service engineer reported an issue with the axiom iconos r200 unit.During preventative maintenance it was identified that the safety bolts for tilting motion were dislodging from base.Furthermore, the rail of the patient table for attaching the footrest was damaged.Provided pictures showed system damage.One of the rails for fastening the footrest was partly detached at the foot end of the table.The bolts of the tilt mechanism were slightly dislocated on both sides of the system.There are no injuries attributed to this event.The reported event occurred in (b)(6).

Manufacturer Narrative

The issue was investigated in detail.During regular maintenance deviations and damage were found at the bearing of the tilt axis and on a profile rail of the tabletop for fastening the footrest.Additionally, the zipper hose (cable protection) underneath and on the back of the table was damaged.Bearing of the tilting axle: based on the provided photos, deviation on both sides can be seen regarding the bearing of the tilt axis.According to the available data and information, it is probable that excessive external forces have been applied to the bearing, which led to displacement of the bearings and resulted in damage of the locking bolts (locking screw).It is assumed that due to the displacement of the bearings for the tilt axis, the unit frame or the segment for holding the (tilt) chain and the doctor-side leg of the tilt foot were already so close to each other that they grind against each other.If the axle is damaged, bent, etc., it is strongly recommended to replace it.In the worst case, if the axle mount on the implement frame is damaged, the entire implement frame would have to be replaced.According to the information received, the system is out-of-service until further repairs.Profile rail of the tabletop: the damage to the doctor's side profile rail at the foot end of the tabletop could only be caused by massive external force.This can happen, for example, if the footrest was hooked in incorrectly and it collided with the floor while tilting upwards.It is operator's responsibility to ensure that there are no objects in the way of system movement (axd3-340.620.14.01.02 pages 30 and 38).Due to the damage to the table rails, the footrest should no longer be used until it has been repaired, as there is a risk of the footrest becoming detached.The repair of the table can be performed with spare part tabletop assembly cpl.(7033611).The spare part consumption of the concerned part tabletop assembly (7033611) shows values that are below the defined threshold.The footrest was requested for investigation but was not provided.Therefore, a detailed root cause analysis of this part was not possible.It is strongly recommended to replace the affected footrest.Cable protection: no damage to the insulation of the individual cables can be seen in the pictures.To reduce further tearing of the zipper hose and, if necessary, external damage to the individual cables, the defective zipper hose should also be replaced.Siemens has received information that the concerned system is in process to be taken out of operation.

• 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: 12892059
• MDR Text Key: 287341244
• Report Number: 3004977335-2021-06266
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 11/30/2021

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: 10093962
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 11/30/2021
• Supplement Dates Manufacturer Received: 03/23/2022
• Supplement Dates FDA Received: 03/23/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other