MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG ARTISTE MV; ACCELERATOR, LINEAR, MEDICAL

Model Number 08139789

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Crushing Injury (1797); Insufficient Information (4580)

Event Date 11/30/2023

Event Type  Injury  

Manufacturer Narrative

According to siemens process, every customer is provided a system owner manual, which must be kept onsite with the unit.The de-installation instructions th02-pno.821.02.03.02 are referenced in this system owner manual and can be requested from the local service organization.It contains a step-by-step guide on how to disassemble the unit.These instructions specify that special tools are required for de-installation process.The instructions contain a warning that ¿uncontrolled movement of the gantry due to an out of balance condition can lead to serious injury or death¿ and that a gantry pin must be used ¿to lock out uncontrolled gantry movement whenever the removal of components will alter gantry balance, e.G., flat panel, multi leaf collimator (mlc), waveguide, or counterweight removal.¿ it has been confirmed that the gantry pin was not used following the counterweight removal which resulted in uncontrolled gantry movement.According to the service history of the concerned system, the customer did not make any attempts to contact the local siemens service organization to de-install the system, request the special tools required for system disassembly, or for any further instructions.It is unknown whether the 3rd party vendor was certified or trained to perform the de-installation.Siemens has not been given access to the system and the hospital treatment room has been quarantined.The deinstallation project has been put on hold pending outcome of government investigation.If additional information becomes available, a supplemental report will be submitted.

Event Description

Siemens healthineers ag (siemens) became aware of a work incident that occurred (b)(6), 2023, during the de-installation of the artiste mv system performed by an independent contractor (3rd party) hired by the customer site.The gantry was unbalanced, because the counterweight was already removed by the employees of the 3rd party vendor, which weighs approximately 2.5 tons.The gantry was anchored by using a chain on one side and a rope on the other side.The rope broke causing the gantry to suddenly rotate and strike one of the employees of the 3rd party.The employee was seriously injured and was admitted to a medical facility where he passed away the same day.

Manufacturer Narrative

The concerned issue was investigated by our engineering team with following results.A 3rd party company was commissioned by the customer to de-install the artiste mv system.The 3rd party vendor engaged another subcontractor.The attempt to de-install the machine occurred on (b)(6) 2023.Siemens healthineers was not contacted either by the customer or the 3rd party vendor; siemens healthineers was not involved in the de-installation of the device.Siemens healthineers was informed about the accident by the varian installation engineer, who reported installation delay of the new replacement system.All information needed for system de-assembly is available at customer sites.The main information can be found in the system owner manual (¿blue binder¿ - ¿disposal instruction¿ ¿ th02-pno.861.01.Xx.Xx).All relevant documentation was reviewed by siemens healthineers and found to be complete and appropriate.The siemens artiste mv system did not malfunction; the medical device including its labelling met all specifications.This incident has been classified as a workmanship error with no contribution from the siemens artiste mv unit.No corrective actions for the installed base are deemed necessary.

• Brand Name: ARTISTE MV
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; röntgenstrasse 19-21; kemnath 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; röntgenstrasse 19-21; kemnath 95478 ; GM 95478
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843274197
• MDR Report Key: 18348709
• MDR Text Key: 330814220
• Report Number: 3006894636-2023-00000
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K072485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 08139789
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 02/23/2024
• Supplement Dates FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2006
• 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
• Patient Outcome(s): Life Threatening