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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is on-going and a supplemental report will be submitted upon completion.

Event Description

The customer notified siemens on july 21, 2017 of an uncommanded table movement that occurred after a patient had been properly positioned.It is reported that the patient noticed the table movement when the technician was leaving the treatment room.The patient informed the technician of the movement and the technician checked the table and found that the table had moved in a vertical direction and rotated isocentrically however no interlock occurred.It is reported that the customer stopped all other treatments for that day and discontinued use of the system.There is no report of injury or mistreatment to a patient.This reported issue occurred in (b)(6).

Manufacturer Narrative

Siemens received both left and right defective table side controls as well as the error log of the whole txt table and conducted a thorough investigation that included a review of the error log provided, visual inspection of both side controls (left & right) and various tests under radiation.Test results for the right side control indicates that the keypad controller was no longer fully functional due to the amount of radiation exposure.Test results for the left side control showed no defects.Records review of the table side controls and analysis of spare part consumption shows that the average mean time to failure (mttf) for these parts are between 9 - 10 years.The defect for the reported issue is considered to be from normal wear of the components.Both the left and right table side controls were replaced and the system is functional.There is no further corrective action initiated.

• Brand Name: ARTISTE MV SYSTEM
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHINEERS GMBH; roentgen strasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; roentgen strasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer Contact: marlynne galloway ; 40 liberty boulevard; mc: 65-1a; malvern, PA 19355-9998 ; 6104486471
• MDR Report Key: 6770381
• MDR Text Key: 81937214
• Report Number: 3002466018-2017-88972
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K060226
• 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,Followup
• Report Date: 12/06/2017,07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2017
• Distributor Facility Aware Date: 07/21/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/06/2017
• Date Manufacturer Received: 11/13/2017
• 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