MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SYNGO RT THERAPIST WORKSPACE V4.3.1; ACCELERATOR, LINEAR, MEDICAL

Model Number 8162815

Device Problem Retraction Problem (1536)

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

Event Date 04/10/2019

Event Type  malfunction  

Manufacturer Narrative

Siemens completed a technical investigation of the reported event.The root cause is that there are some scenarios where the fpp might strike/touch the patient or the treatment table during the auto-retraction movement, depending on the patient positioning and/or the table positioning.This kind of scenario applies only to automatic fpp movements due to the special auto-retraction path of the positioner (which is a curved path because all motors are moving simultaneously).If a collision occurs during these scenarios, it would be a soft touch rather than a hard impact.A moderate patient injury could result, however, if even a soft collision occurred.When automatically retracting, the fpp performs two movements simultaneously.As a consequence, the fpp's edge may lift up a bit depending on the initial z-position.If there is too little clearance between the fpp's edge and the treatment table, the fpp's edge could touch the treatment table.The collision detection system would then activate the motion stop interlock.It is recommended that clearance considerations be made during treatment planning.(b)(6).

Event Description

It was reported to siemens that the customer complained there is a risk that the treatment table and flat panel positioner (fpp) may collide when the fpp is retracted automatically, especially if the syngo.Rt therapist fpp is retracted automatically after 2d imaging.There was no report of patient injury or patient mistreatment.

• Brand Name: SYNGO RT THERAPIST WORKSPACE V4.3.1
• 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: 8560594
• MDR Text Key: 161435974
• Report Number: 3002466018-2019-77454
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K132935
• 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
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8162815
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/10/2009
• 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