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

Model Number 10094200

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 10/28/2021

Event Type  malfunction  

Manufacturer Narrative

It is currently assumed that the issue of the bent mounting bracket, resulting in the detached chain, was caused by a collision.When the chain detaches from the mounting bracket, a safety circuit is activated, which blocks any further system movement.It is currently unclear how the collision of the table frame with the floor could happen.Normally described tilting movement can only be performed if service buttons are activated.It is possible that the reported collision with the floor took place while the system was in override mode.The operator manual includes a section on "risk of collision" and cautions about prevention of damage or persons from being injured.If a person is in the way of the table hitting the floor, in worst case a serious injury might occur.However, the part of the system that collides with the floor is difficult to reach and an operator would not have his foot there accidentally during operation of the system, it is assumed that such injury would not happen should the issue recur.It is user's responsibility to avoid any collision.Siemens is conducting a thorough investigation of the reported incident.A supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).

Event Description

Siemens became aware of an incident with the axiom luminos drf unit.The chain for the lifting movement detached from its mounting bracket.The bracket was found to be bent.It was communicated that the user made an unsuccessful attempt to lift the table and then he tilted the table.The tilt movement resulted in the table colliding with the floor.No injury or patient involvement was communicated for this event.The reported event occurred in (b)(6).

Manufacturer Narrative

The issue was investigated in detail.According to the information received, the operator wanted to move the table upwards using the lift button.The operator noticed that the lifting movement was not triggered.He then tilted the table foot wards in the low lifting position.In order to achieve the ground clearance required for tilting, a lifting movement is normally generated in addition to the tipping movement, however, this has not occurred.The unit collided with the floor at the foot end.Following the collision, it was found that the chain of the lifting axis had completely detached from its mounting and the mounting was also damaged.The investigation of the log files showed that on (b)(6), 2021, at 9:11 a.M., error 3074 had occurred, stating that there was an unusual deviation in the positions.The axes were then stopped, and the safety circuit was opened causing the unit to restart.When the hub was controlled again, the same error message was generated twice.Due to the blocking of the lift axis in normal operation, the "safety movement" was activated at 09:56 a.M.At this time error 152 from the basic unit could be found for the first time in the analyzed log file.This means that a potentiometer no longer produces plausible values and the so-called "safety movement" was activated.During "safety movement" the axle only moves a few centimeters with each control and without collision monitoring.Therefore, it is mandatory to drive with increased attention during the control.After these few centimeters of movement, the axle stops despite continued key actuation and the key must be pressed again to continue the movement.All movements are only possible step by step and an acoustical warning signal sounds on actuating and during the movement (see also axd3-500.620.02.02.02; page 137).This operating mode was implemented to be able to approach a position for patient rescue if one or more axes are blocked.Further on, until 10:18 a.M., the system was activated many times which each time generates an error 152 in the log files and was also displayed to the operator.It was found that the collision calculation had determined that the unit was in a prohibited collision range.It is not clear whether the position value of the stroke axis was correct, as it was communicated, or incorrect.The last plausible position value of the lifting axis before the event was 60 cm, which is only 10 cm above the minimum height.For collision-free tilting to 90°, the position value of the lifting axis would have to be 100 cm.At a working height of approx.60 cm (last plausible value) and at a tilt of 18°, a ground collision is inevitable.At the moment of the ground collision, when the tilt movement was continued, a force was introduced into the lift axis, which acts upwards.This means that the lift-tilt gear was pressed upwards without the lifting movement being triggered.This force resulted in damage to the lower chain attachment or loosening of the chain.This could also be identified by analyzing the provided pictures.The damaged part was the assembly "chain monitoring for lifting foot" (11232327).The spare part consumption of the concerned part (11232327) shows values that are below the defined threshold.The unit was professionally repaired by a trained service technician and returned to the user fully functional.

• Brand Name: AXIOM LUMINOS DRF
• 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: 12750536
• MDR Text Key: 280103568
• Report Number: 3004977335-2021-03133
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K062623
• 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: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10094200
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other