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

Model Number 8139789

Device Problem Unintended System Motion (1430)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2015

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report due to report error.The original initial report was submitted on 1/8/2016 as mfr report #2240869-2015-28186.Siemens' investigation into the reported event is on-going and a supplement report will be submitted upon completion.(b)(6).

Event Description

Siemens was notified on december 10, 2015 that there were two separate events on (b)(6) 2015 where an issue occurred with sporadic gantry movement in the wrong direction during either auto sequencing or by manual target position entry.However, after some degree of movement, interlock #63 (controller #0) with error #53 would appear or interlock #92 (gantry movement) with error #55 would appear.It is reported that the customer pressed the motion stop button each time the issue occurred and there is no report of mistreatment or injury to a patient.This reported issue occurred in (b)(6).

• Brand Name: ARTISTE MV SYSTEM
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; roentgenstrasse 1; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer Contact: marlynne galloway ; 40 liberty boulevard; mail stop: 65-a; malvern, PA 19355-9998 ; 6104486471
• MDR Report Key: 8569777
• MDR Text Key: 166522173
• Report Number: 3002466018-2016-28186
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: LE
• PMA/PMN Number: K123812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• 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?: No
• Date Manufacturer Received: 12/10/2015
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1