MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ACCELERATOR, LINEAR, MEDICAL; ARTISTE MV

Model Number 8139789

Device Problem Unintended Collision (1429)

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

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

The initial reporter's name was not provided to siemens and the event was reported by a siemens employee.Siemens has completed the investigation of the reported event.The event log confirmed that on (b)(6) 2021 at 09:25:34.278, a motion stop was asserted by the treatment table caused by the collision which prevented further damage.The root cause is unknown.If the customer does not pay attention during manual movement, and has not verified collision clearance, it might lead to a collision event in which the patient could sustain a severe injury.As stated in the system user manual, the user must always be aware that the automatic motion protection (amp) system is not active during manual movement of the gantry, the treatment table or the collimator.

Event Description

It was reported to siemens by the customer that during use of the artise mv system on a patient, when he rotated the gantry from the control console (cc) of the linac, the gantry collided with the treatment table at approximately a 205 degree gantry angle.The patient was positioned on a breast board mounted to the treatment table.Fortunately, the patient was not injured during the collision.Although no patient injury occurred due to the reported issue, there is still potential patient risk of severe injury if this issue were to reoccur.This event was reported with an abundance of caution.

• Brand Name: ACCELERATOR, LINEAR, MEDICAL
• Type of Device: ARTISTE MV
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486484
• MDR Report Key: 11503072
• MDR Text Key: 248824512
• Report Number: 3002466018-2021-69629
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8139789
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1