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

Model Number 8139789

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

The initial reporter is a siemens employee.Reporting facility phone number is (b)(6).Siemens has initiated a technical investigation of the reported event.The root cause has not been identified.A supplemental report will be submitted upon the completion of the investigation.

Event Description

It was reported to siemens that when the customer tried to move the txt treatment table, the table dropped down a few centimeters (exact number of centimeters unknown).Although no patient injury or mistreatment was reported, in a similar scenario if the table drops unexpectedly, the patient may be frightened and fall from the table.This fall could result in a severe injury which may require medical intervention.This event is being reported with an abundance of caution.The reported event occurred in (b)(6).

Manufacturer Narrative

Siemens performed a detailed technical investigation of the reported event and system.The following complaint part was available for investigation: freq.Inverter lti cdb32.004 (motor controller of the vertical axis with part number 8673530).The returned part was tested in test lab, and it was found that the output circuit (power amplifier) of the frequency controller was defective.The exact root cause of this failure was not identified.The controller defect occurred immediately after the customer tried to move / be moving the table up (manual movement).With the implemented design, the table movement of all axes will be stopped immediately after an unintended movement of 2mm +/- 1,5mm and a motion stop (interlock to prevent from treatment to wrong location) will be asserted.In this very short time frame the table can sag a small distance downwards.This distance depends on the patient weight and cannot be exactly specified.Such an unlikely unintended movement is only possible if following errors occur: 1.Absolute encoder of the vertical axis is defective during movement of the axis 2.Frequency converter of the axis is defective during movement of the axis 3.Frequency converter of the axis is defective at movement beginning.The defective component was exchange and the issue did not reoccur after the replacement.The spare part consumption of the encoder (pn 08673530) was checked and found at a low level with decreasing tendency.No remedial action is deemed necessary.

• Brand Name: ARTISTE MV
• 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: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 11018952
• MDR Text Key: 251317498
• Report Number: 3002466018-2020-56342
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K142434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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?: No
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1