MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTISTE MV; MEDICAL CHARGED-PARTICLE RADIATION THERAPY SYSTEM

Model Number 08139789

Device Problems Human-Device Interface Problem (2949); Inadequate User Interface (2958)

Patient Problem Bruise/Contusion (1754)

Event Date 07/13/2016

Event Type  Injury  

Manufacturer Narrative

The original initial report was submitted on date as mfr report #2240869-2016-04473.On (b)(4) 2016 siemens engineer was notified about an incident that occurred with a patient (b)(6) 2016.Due to a long time span the log files were no longer available on the machine as they had been overwritten.According to the provided data the gantry moved from 345 degree to 63.7 with travelling time approximately 13 seconds.The user had sufficient time to release the pressed keys on the console or push the red emergency button to stop all systems movements.It was confirmed that the customer is aware of potential risks and regular trainings take place to educate personnel about these risks.This report was submitted august 18, 2016.Customer's address: (b)(6).

Event Description

Siemens became aware of an incident that occurred on the artiste mv system.Prior to moving the treatment table with a patient on it, the user manually moved the gantry at the control console.During the gantry movement the patient was not monitored and a collision with patent's legs occurred.The patient suffered from bruises on his legs.The incident occurred with cameras and intercom fully functioning and two radiation therapists present in the room.The reported event occurred in (b)(6).

Event Description

Siemens became aware of an incident that occurred on the artiste mv system.Prior to moving the treatment table with a patient on it, the user manually moved the gantry at the control console.During the gantry movement the patient was not monitored and a collision with patent's legs occurred.The patient suffered from bruises on his legs.The incident occurred with cameras and intercom fully functioning and two radiation therapists present in the room.The reported event occurred in new zealand.

Manufacturer Narrative

Resubmission of initial report due to report error.The original initial report was submitted on 08/18/2016 as mfr report #2240869-2016-04473.(added date of original report sent).Type of report - initial, follow-up #1.August 1, 2016 siemens engineer was notified about an incident that occurred with a patient (b)(6) 2016.Due to a long time span the log files were no longer available on the machine as they had been overwritten.According to the provided data the gantry moved from 345 degree to 63.7 with travelling time approximately 13 seconds.The user had sufficient time to release the pressed keys on the console or push the red emergency button to stop all systems movements.It was confirmed that the customer is aware of potential risks and regular trainings take place to educate personnel about these risks.This report was submitted august 18, 2016.Customer's address: (b)(6).

• Brand Name: ARTISTE MV
• Type of Device: MEDICAL CHARGED-PARTICLE RADIATION THERAPY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• MDR Report Key: 8566255
• MDR Text Key: 143600913
• Report Number: 3002466018-2016-04473
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• PMA/PMN Number: K142434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 08139789
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/01/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other