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

Model Number 10762472

Device Problems Unintended System Motion (1430); Unintended Movement (3026)

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

Event Date 10/14/2021

Event Type  malfunction  

Manufacturer Narrative

All system movements can be stopped at any time by pressing the emergency red stop button.A falsely activated control button can potentially be identified by the system during startup.In this case an error message would be displayed, and the system cannot be operated further.It is assumed that the described fault occurred after startup.The investigation is on-going.A supplemental report will be submitted if additional information becomes available.(b)(4).

Event Description

Siemens became aware of an unintended system movement on the luminos agile max unit.The table top was in the upright position when it started tilting downwards without given command.The incident occurred during a patient exam with a patient on the table.The reported event was a single time occurrence with no injuries attributed to it.

Manufacturer Narrative

The issue was investigated in detail.According to the submitted information, the unit tilted without given command while a patient was lying on it.The investigation of this issue consisted of the evaluation of the log files and the visual inspection at the customer site by a service technician.The investigation of the log files did not show any deviations regarding "movement without control" during the time of event.For every movement, a request (key press) and a dmg signal were confirmed.The tilt movements are only triggered if the necessary requirements (key press for tilt and dmg signal) are fulfilled.It was found that during system start-up the tilt-motion button on the optigrip was unintentionally activated (possibly the control button froze or was defective).Unintended tilt movement could be triggered when activating the hardware circuit (dmg) at any other operating location of the unit (e.G.When activating another movement button) caused by a defect.Following the reported event, a permanent operating signal "tilt_down" was detected on the optigrip during system start-up by the control monitoring (buttons, joysticks, etc.), which led to a system-side blocking of the operating element (button "tilt_down" on the optigrip).With this deactivation of the defective control element, a repetition of the malfunction is excluded.The investigation by the involved service technician at the concerned customer site showed that the optigrip appeared to be damaged.The damage of the optigrip was probably caused by external force.The affected optigrip was requested for a deeper analysis.However, according to the information received by the service technician, the part had been already scrapped.Therefore, no further investigation of the affected part was possible.The spare part consumption of the concerned optigrip (material number 10657026) shows values above the defined threshold.This high part consumption was analyzed with the result that it was caused by cracks in the housing not due to freezing of the buttons.Based on the investigation results the unintended movement was most likely caused by a "hanging" tilt button on the optigrip which triggered an unintended movement during the simultaneous activation of the dmg at any other operating location of the unit.In general, unintended movements can be stopped immediately by using emergency stop buttons on the unit.The concerned unit was repaired by a trained service technician and returned to daily operation.

• Brand Name: AXIOM LUMINOS AGILE MAX
• 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: 12667911
• MDR Text Key: 281274917
• Report Number: 3004977335-2021-01021
• Device Sequence Number: 1
• Product Code: JAA
• UDI-Device Identifier: 04056869009162
• UDI-Public: 04056869009162
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

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: 10762472
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2021
• Initial Date FDA Received: 10/20/2021
• Supplement Dates Manufacturer Received: 02/10/2022
• Supplement Dates FDA Received: 02/25/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other