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

Model Number 10094200

Device Problems Use of Device Problem (1670); Unintended Movement (3026)

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

Event Date 09/22/2020

Event Type  malfunction  

Manufacturer Narrative

The table side control was replaced by siemens local service.The root cause of the unintended movement is unclear.Siemens is conducting a thorough investigation.A supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).

Event Description

Siemens was informed about unintended movement of the axiom luminos drf device.The user reported that the unit moved without given command, and damaged a patient table.The user also stated that the movement control button on the table side control button is very sensitive, and does not need to be pressed to initiate a movement.There is no patient involvement in this case.No injuries are attributed to this event.The reported incident occurred in (b)(6).

Manufacturer Narrative

The issue was investigated in detail.During the visual inspection of the returned tableside control board, several mechanical influences could be identified several slight deformations (dents) on the control unit were identified.The component "tableside control, 10252050" is used in the device "basic unit luminos drf (buc), 10252000".This unit does not have dmg functionality (dmg = dead man grip).At the time of the development this functionality was state-of-the-art feature.With an integrated dmg function, an additional hardware-based switching level is used for motion-triggering control elements parallel to the software-based control/signal level.Both signal levels must be activated simultaneously to trigger a movement.If one of the two signals is missing, the movement will not be started or the movement process will be stopped.The evaluation of the keys within the component is done via a key matrix.To test the function of the keys a measuring instrument with the function diode test was used.Therefore, every key was pressed, and the result of the diode tester was observed.This diode test showed that the button s227 (moving the x-ray system longitudinally) and, therefore, the diode d2 were defective.This could also be seen visually on the part.The s215 key (lift down) is noticeably defective, however, the diode test did not show any deviations.There is a weak resetting force of the snap disk of the button.The examination of the "lift down" button showed a weak resetting force of the button.In the period under examination, this resetting effect was still sufficient, and the test of the key function did not show any failures.However, it cannot be ensured that this was or is always given.This deficiency could be the cause for an unintentional movement of the lift axis.The cause of the error pattern communicated could be the insufficient resetting force of the snap dome of the s215 button.A mechanical effect was detected in the vicinity of this button.This effect could have influenced the resetting force of the snap dome.Due to this reduced resetting force, it is possible that the button does not always return to the unactuated position, which may cause an unwanted movement.In addition, if a permanent operating signal is detected by the control monitoring system (buttons, joysticks, etc.) when the device is started up, the affected operating element will be deactivated by system.The provided log files did not cover the time of the event.However, this type of an incident would not have been recognized in the log files as from the software's point of view it was a normal control on a button of the table side control.In general, unintentional movements can always be stopped by pressing the emergency stop button provided on each device.The issue was solved at the concerned site by siemens local service technician with replacement of the affected part.

• 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: 10614199
• MDR Text Key: 209418661
• Report Number: 3004977335-2020-48009
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

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: 10094200
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 12/04/2020
• Supplement Dates FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other