MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH LUMINOS DRF MAX; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10762471

Device Problem Unintended Movement (3026)

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

Event Date 10/11/2023

Event Type  malfunction  

Event Description

Siemens became aware of a malfunction while operating the luminos drf max system.Unintended system movement without any action triggered by the user was reported.No injury was communicated in this case.It is assumed that in worst case a minor to serious injury might be the outcome should a person be hit by an unexpectedly moving column.

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be submitted if additional information becomes available upon completion of the investigation.

Manufacturer Narrative

Siemens healthineers completed the investigation of the reported issue.It was initially stated that the tube column moved without any command from the user.It was furthermore stated that the customer did not touch the joystick, but the movement started when they came close to it.It was confirmed that the customer¿s hands are always close to the joystick.The likelihood of the dmg being activated by this is high because the joystick has a built-in capacitive sensor to provide the dmg signal.Despite the request not to use the system until it was repaired, the customer decided to continue using the system.In this case, further unintended movements of the system cannot be excluded.The problem was finally solved by the service organization with replacement of the joystick module 5 multifunc.Joyst.(material number 11547992).This part controls the described longitudinal movement of the tube/detector.The suspected joystick was returned as complaint part and investigated in detail.The part was connected to a remote-control console of a test system in the lab.It was found that when the dmg of the joystick was activated by bringing the hand close enough to be recognized by the dmg sensor (typical detection distance: approximately up to 1cm from the joystick housing), the tube/detector longitudinal axis immediately began to move at full speed in foot-ward direction (no touching or actuation of the joystick in any direction).When the dmg was disengaged (hand moved out of sensor range), the movement stopped immediately.Since the investigation confirmed internal damage of the affected joystick, the provided log files were no longer relevant for investigation.Shs internal post market surveillance does not indicate a general problem for the affected part.Other parts that might have been replaced during troubleshooting are not relevant for the described complaint topic and were therefore not considered for investigation.On (b)(6) 2023, the customer confirmed that the issue did not recur after replacement of the defective part.Since no general problem was identified the complaint was closed without further measures.

• Brand Name: LUMINOS DRF MAX
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr. 1 or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 17956798
• MDR Text Key: 325927343
• Report Number: 3004977335-2023-00132
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869009155
• UDI-Public: 04056869009155
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K173639
• 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: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10762471
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1