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

Model Number 8139789

Device Problem Mechanical Problem (1384)

Patient Problem Injury (2348)

Event Date 03/18/2016

Event Type  Injury  

Manufacturer Narrative

Siemens investigation into the reported event is on-going and a supplemental report will be submitted upon completion.

Event Description

The customer informed siemens on (b)(6) 2016 that during automatic gantry-movement to 180° in counter-clockwise direction starting from 0° within an autosequence (afs), a collision between the accessory holder and the arm of a patient occurred on (b)(6) 2016.To achieve a correct patient positioning the table top was moved all the way to the left at lateral axis when the incident occurred.It was reported that the patient suffered minor skin injuries on their arm.The patient's status is unknown at this time.The reported incident occurred in (b)(6).

Manufacturer Narrative

Siemens has conducted a thorough investigation of the reported event.The incident was reconstructed based on the dmip logfile.For all segments, the isocentric and eccentric table positions are 0°.Based on these positions, the automatic motion protection feature considers the movement from segment 2 to segment 3 as safe and automatic gantry motion was allowed.It is also specified in the system user manual, when performing a dry-run, that the gantry will rotate counter clockwise if the travel distance is identical in both directions.Therefore, the system was operating according to specifications.

• Brand Name: ARTISTE MV SYSTEM
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; medical solutions; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; medical solutions; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer Contact: meredith adams ; 40 liberty blvd; 65-1a; malvern, PA 19355-9998 ; 6104486461
• MDR Report Key: 5544744
• MDR Text Key: 41772722
• Report Number: 2240869-2016-01793
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Service Personnel
• Type of Report: Initial,Followup
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8139789
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2016
• 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
• Patient Outcome(s): Other