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

Model Number 10094200

Device Problems Unintended Collision (1429); Use of Device Problem (1670); Defective Component (2292)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

It is assumed that the issue was caused by a defective potentiometer.In this case unit normally stops all system movement and an error message is displayed.This failure situation is described in the user manual as well as the possibility that the operator can initiate further movements in a step by step manner and under his control (e.G.To operate the table into a position to take the patient off the system).In the reported case no unintended movement or unintended continuation of movement occurred.It is assumed that the user initiated patient table movement by actively using the override function.In the override mode the safety mechanisms against collision are deactivated.Therefore, the system movement is in the responsibility of the user.The defective component was replaced on the concerned unit.The investigation is on-going, a supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).

Event Description

Siemens was informed of an event that occurred on the axiom luminos drf unit.The device displayed an error message "severe error 152/32" and the patient table had been tilted all the way down until it hit the floor.No patient involvement was reported in this case.There are no injuries attributed to this event.

Manufacturer Narrative

The issue was investigated in detail.The described behavior can be caused if the unit is being operated while the system has already detected a serious error and switched into "safety drive mode".The investigation of the provided log files confirmed this situation.The position monitoring has determined that either no movement has been carried out or that one position is outside the permitted range (potentiometer error).The drive would remain blocked until the error is rectified or the system is restarted.If the error is pending, other device movements can be carried out with safety run.During the safety run, the collision limits are removed, and the controlled axis moves very slowly over a short distance.The activation must be triggered again and again, and the movement is signaled by an accompanying warning tone.All axes can only be moved a short distance and then must be controlled again to move further.In this situation only if a patient needs to be rescued, then service should be called in.A normal patient operation will no longer be allowed.This information is stated within the operating instructions axd3-500.620.02.02.02, page 136/137.During investigation it was found that the last movement of the table lift axle was just before the end position.After the error was recognized, the system was rebooted shortly three times in a row.Within the last boot sequence, the error 161/032 appeared (collision calculation recognized a movement which was too far in the unlimited mode).Since the flightrecorder is usually offline in version vb10, the exact positioning of the system at the time of the collision could not be determined.According to the system investigation at customer site, the table lift potentiometer jumps all over the normal values.After performing a potentiometer adjustment, the system worked fine for about 3 cycles.After that, the table jumped into the safety switch again.Therefore, the defective potentiometer was exchanged.Since the part replacement no further issues have been reported from the concerned unit.The investigation indicated that since the error messages were ignored, the system was brought into a position, which was close to a collision.Another override of the error state made it possible to collide with the floor.It is the responsibility of the operator to ensure that unit movements are released only if it is certain that neither the operator, the patient, third parties nor any piece of equipment can be endangered by these movements.This is also stated within the operating instructions axd3-500.620.02.02.02.Internal id # (b)(4).

• 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
• MDR Report Key: 10302472
• MDR Text Key: 220730641
• Report Number: 3004977335-2020-38453
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K062623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10094200
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other