MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MEVATRON M2; ACCELERATOR, LINEAR, MEDICAL

Model Number 1940035

Device Problem Unintended System Motion (1430)

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

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

Udi is unknown for this system.Occupation: initial reporter is a siemens employee.Reporting facility phone number was not provided.Additional contact information has been requested.Siemens has initiated a detailed technical investigation of the reported events.The root cause is unknown.A supplemental report will be provided upon the completion of the investigation.

Event Description

It was reported to siemens that there was an issue with the 550 txt patient table on december 18, 2020.During patient therapy, when the gantry rotates from one field to another from the keyboard in the command room, the patient table itself begins to move isocentrically.After resetting, the table continued working.On december 21, 2020, the facility physicists reported the same issue with the patient table.It was further reported that during the removal of a patient, when moving down, the display suddenly shows zeros and the movement is blocked.Primus was also not functioning.Although no patient injury or mistreatment occurred during these reported events, in a worst-case scenario, unintended movement of the treatment table could lead to severe patient injury.This report is being submitted with an abundance of caution.The reported event occurred in (b)(6).

Manufacturer Narrative

The returned table side control was investigated by the engineering team.No malfunction was identified; the side control unit worked as specified.Additionally, an investigation of the relevant treatment data (savelogs and table error logs) were requested by the investigation team.However, the requested data for the time of the reported event was not available for analysis.Therefore, the root cause of the incident described could not be determined.According to the last service onsite visit, the concerned system functioned as intended.No further investigation is possible, no general design issue has been identified.

• Brand Name: MEVATRON M2
• 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 ; 6104486484
• MDR Report Key: 11130725
• MDR Text Key: 234231946
• Report Number: 3002466018-2021-60961
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: BU
• PMA/PMN Number: K882729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1940035
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: No
• 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