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

Model Number 8139789

Device Problem Use of Device Problem (1670)

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

Event Date 10/10/2019

Event Type  malfunction  

Manufacturer Narrative

No mistreatment or injury of a person have been reported.The user recognized the failure and called the service engineer.After replacement of the damaged cover the issue has been fixed.A serious injury can result if the treatment table collides with the accessories and the patient is squeezed.It is stated in the instructions for use to be always aware that the automatic motion protection system (amp) is not active during manual movement of the gantry, the treatment table or the collimator.Siemens is providing a system which is safe regarding patient safety if used as described in the intended use and the instructions for use.No systematic issue in the installed base could be identified.No additional risk to the patient could be identified.

Event Description

It was reported to siemens that a malfunction occurred while operating the artiste mv system.The user reported that he lowered the table and hit in between a trolley resulting in one of the bellow covers breaking.There is no report of impact to the state of health of any patient or user involved.

• Brand Name: ARTISTE MV
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; kemnath, germany 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; doris ruppenstein str. 4; erlangen, germany 91052 ; GM 91052
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 9504284
• MDR Text Key: 195437102
• Report Number: 3002466018-2019-10208
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K072485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• 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: 12/02/2019
• 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: N
• Patient Sequence Number: 1