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

Event Date 06/11/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of this event.The cause for the issue has not been determined yet.A supplemental report will be submitted if additional information becomes available.(b)(4).

Event Description

Siemens became aware of an unintended table movement of the axiom luminos drf unit.The issue occurred during patient examination.No medical intervention was required in this case.There are no injuries attributed to this incident.The reported incident occurred in (b)(6).

Manufacturer Narrative

The investigation showed that following system startup the device detected a failure (error 252/034) at the multifunction joystick.This indicates that the rcc1 multifunctional joystick was activated during power on.When the user tried to move the table, the movement with this joystick on remote-control was blocked.Movements from other control elements remained possible.According to the log file analysis no malfunction could be found as the manufacturer was unable to determine if the movement was activated by the user or caused by a defect in the control element.For vc10 sw-version no dmg (dead man grip) function is available as the system was designed according to the iec-standard (second edition).The replaced and returned remote-control console was investigated by our supplier.It was installed on a test system.No error message was displayed following system startup.The event communicated by the service technician (signal unintentional active without operator action) could not be reproduced on the test system.On the multifunction joystick the x-axis shows no function (safe state); no deflection of the x-axis was detected.The y-axis of the multifunction joystick was working properly.The multifunction joystick on the console was replaced and following the replacement the y-axis showed no function.By repeatedly pressing the contact strip on the ribbon cable to the connection strip of the joystick, the x-axis and the y-axis were functional again.After identifying the contact problem, the returned multifunction joystick was reinstalled.The x-axis and the y-axis of the joystick were now also functional.All other joysticks and buttons did not show any abnormalities.Based on these results, a contact fault was identified as the root cause of the described issue.A bad contact can cause several error effects.A permanent control signal from the joystick is also possible since the 0-position of the analog joysticks corresponds to 2.5v.Therefore, no contact (corresponds to 0v) is understood as a starting of movement.The described device is a system that does not have an additional hardware release (dmg).In this case a contact error could have caused an unintended movement.However, when the device is started up, such contact problem should be detected by the control monitoring, the affected control element will be deactivated and an error message will be displayed.If a contact error occurs in the worst-case scenario after the startup and an unintended movement occurs, this can be stopped immediately with the emergency stop button on each control unit of the device.To prevent such contact problem at the joystick, the ribbon cable should be replaced as well.It is included in the spare part set of the joystick.Within the replaced and returned component the original spare part ribbon cable was found which indicates that it was not replaced with the joystick.The spare part consumption of the concerned part (material number 10308484) shows values that are below the defined threshold.Since replacement no further issues are known from the concerned site.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: 10183733
• MDR Text Key: 196074199
• Report Number: 3004977335-2020-33694
• 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: company representative,foreig
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 06/23/2020

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: 06/12/2020
• Initial Date FDA Received: 06/23/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other