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

Model Number 8139789

Device Problems Unintended Collision (1429); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens received information from the customer that the gantry moved in the right direction.The customer rotated the gantry manually from outside the bunker.The customer admits that the issue occurred due to user error.Based on the information provided by the customer, siemens did not evaluate the reported system.As stated in the user manual always be aware that the automatic motion protection system (amp) is not active during manual movement of the gantry, the treatment table or the collimator.(print no.T2-000.629.33.05.02 p.60).Siemens has determined no further action is necessary at this time.

Event Description

It was reported to siemens that while the patient was in a supine (head first) position, the gantry rotated down the right side of the patient, counter-clockwise instead of the gantry rotating down the right side of the patient, clockwise.This unexpected gantry movement caused the collimator to collide with the edge of the treatment table, in the area of the patient's shoulder placement.There was a large table offset of 14.1.However, there is no report of mistreatment or injury to a patient.It was reported that the user moved the gantry manually, from outside of the bunker.The gantry moved in the right direction according to controlled guidance, which was in error by the user.Though no injury occurred due to the reported event, a critical patient injury could occur if the error is repeated.This report is being submitted with an abundance of caution.

• 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: marlynne galloway ; 40 liberty boulevard; malvern, pa ; 4486471
• MDR Report Key: 10279564
• MDR Text Key: 214801515
• Report Number: 3002466018-2020-35824
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2020
• Was Device Evaluated by Manufacturer?: No
• 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