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

Model Number 8139789

Device Problems Break (1069); Unintended Collision (1429)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation showed that the collision occurred while the system was being operated by an (b)(6) student operator with no supervision from a healthcare professional.The edge of the table top was damaged due to the collision.Siemens does not recommend the operation of the system by persons not supervised and not trained on system use.The system is designed to be operated by professional staff only.Instructions for the system's use suggests that during manual movement of the table using the hand control, the operator has to stand beside the treatment table inside the bunker when operating the system to ensure visual control of the system.Furthermore, during manual movement the user should monitor the system at all times and release the dead man switch to stop any movement in case of potential collision.All other staff should press one of the motion stop buttons to prevent a collision.Siemens' recommendation to the customer was to replace the table top however the customer declined the replacement and is choosing to repair the damage in-house.The system worked as specified and this reported incident is deemed to be user error.Considering this, no corrective action is initiated.

Event Description

Siemens was notified on april 3, 2017 that the txt550 table top was broken at the edge when the handles of the hard wedge that was inserted in the accessory holder collided with the table during a manual rotation of the gantry by use of the hand control.There is no report of mistreatment or injury to a patient.This reported issue occurred in (b)(6).

• 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: 6491392
• MDR Text Key: 73024816
• Report Number: 2240869-2017-76194
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K121295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/27/2012
• 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
• Treatment: TXT550 TABLE TOP