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

Model Number 8139789

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 01/30/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation is on-going and a supplemental report will be submitted upon completion.(b)(6).

Event Description

The customer informed siemens on (b)(6) 2017 that after moving different translational table axis, the rotational value of the column axis was incorrect by 0.8°.The user confirmed that only the value on the display changed from 0.0° to 0.8° however the actual table position was at 0.0°.It is reported that this was a single event for one patient and there is no report of injury or mistreatment as the user recognized the deviation of the display value and the value of the actual table position.This reported issue occurred in (b)(6).

Manufacturer Narrative

The system has been checked locally by the siemens service engineer.No malfunction has been identified.The sensor and the magnetic brakes have been replaced and returned for investigation.The parts were integrated in a 550txt table for testing.Results of the investigation found that the incorrect system behavior reported by the user could not be reproduced.No other abnormalities have been detected.The sensor as well as the magnetic brakes works as specified.No root cause could have been identified.It is most probable that the display moved by one bit due to neutron interactions.The reported problem is a display issue only.Considering this, no further corrective action is initiated.

• Brand Name: ARTISTE MV SYSTEM
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH AT-RO; medical solutions; roentgen strasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH AT-RO; medical solutions; roentgen strasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer Contact: marlynne galloway ; 40 liberty boulevard; mail stop 65-1a; malvern, PA 19355-9998 ; 6104486471
• MDR Report Key: 6464159
• MDR Text Key: 72264469
• Report Number: 2240869-2017-69043
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Service Personnel
• Type of Report: Initial,Followup
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• 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?: No
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2014
• 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