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

Model Number 8139789

Device Problem Unintended Collision (1429)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2019

Event Type  malfunction  

Manufacturer Narrative

Reporting facility phone number: (b)(6).Initial reporter is a siemens employee.Siemens completed an investigation of the reported event.It was confirmed that the system works as specified.As stated in the associated user manual, the user must always be aware that the automatic motion protection system (amp) is not active during manual movement of the gantry, treatment table or collimator.Further action is not warranted at this time.

Event Description

It was reported to siemens that the treatment table collided with the artiste mv system gantry during use.The customer had moved the gantry manually and stopped rotation of the gantry when the gantry touched the treatment table resulting in a very slight collision.There was no injury to the patient or user as a result of the reported event.In a worst-case scenario, if the user does not pay attention during manual movement and has not verified collision clearance, a collision may occur resulting in severe injury to the patient.This report is being submitted with an abundance of caution.The reported event occurred in (b)(6).

• Brand Name: ARTISTE MV SYSTEM
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• 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: 9586118
• MDR Text Key: 220231520
• Report Number: 3002466018-2020-12605
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• 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: 12/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1