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

Model Number 8139789

Device Problem Unintended Collision (1429)

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

Event Date 03/26/2019

Event Type  malfunction  

Manufacturer Narrative

Siemens conducted a technical investigation of the reported event.The investigation showed that the customer had lowered the treatment table onto a stretcher which resulted in minor bending of the treatment table side covers.The covers were repaired.A functional check of the table revealed it was working correctly.The table movement and resulting collision with the stretcher were not the result of a system malfunction.No additional action is warranted at this time.

Event Description

It was reported to siemens that while the operator was lowering the artiste mv system treatment table during setup, it collided with a stretcher positioned beneath.The collision resulted in minor damage to the artiste treatment table (side covers were bent).Although this event did not result in patient or user injury, moving the treatment table can lead to hand and finger injuries if proper precautions are not taken.Hands and fingers can be pinched between the treatment table and other parts, for example the ct gantry, or other equipment, resulting in moderate bodily injury.

• Brand Name: ARTISTE MV
• 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; doris ruppenstein str; erlangen, 90152 ; GM 90152
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486484
• MDR Report Key: 8495394
• MDR Text Key: 146374499
• Report Number: 3002466018-2019-75492
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• 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?: Yes
• Date Manufacturer Received: 03/26/2019
• 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