MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ONCOR IMPRESSION PLUS; ACCELERATOR, LINEAR, MEDICAL

Model Number 5857912

Device Problem Unintended Movement (3026)

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

Event Date 01/06/2022

Event Type  malfunction  

Event Description

It was reported to siemens that the system treatment table moved unintentionally while the patient was relocated from the patient bed onto the treatment table.The control console (cc) displayed two (2) interlocks (il).The customer observed this behavior twice.There was no reported patient mistreatment or injury to the patient or user because of this issue.In a worst-case scenario, unintended movement of the patient table could lead to severe patient injury.This report was submitted with an abundance of caution.The reported event occurred in (b)(6).

Manufacturer Narrative

Siemens completed the investigation of the reported event.Siemens service could not reproduce the issue and did not find any malfunctioning parts.The treatment table was not able to hold its position due to opened or ineffective breaks.The treatment table did not move by its own force.The device remains single fault safe.The interlocks work as specified.The interlocks would also stop the release of radiation in the event of unintended treatment table movement during patient treatment.The root cause is unknown.It was further reported that there was a lightning strike at the hospital on (b)(6) 2022, which led to a malfunction of a treatment table from the other linac at the hospital.It is not known if this issue contributed to the reported event.Further investigation is not deemed necessary at this time.

• Brand Name: ONCOR IMPRESSION PLUS
• 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: 13306511
• MDR Text Key: 290071994
• Report Number: 3002466018-2022-12235
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5857912
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/06/2022
• 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