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

Model Number 8139789

Device Problem Unintended Collision (1429)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/26/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Siemens has completed a technical investigation of the event.The root cause of this event was user error.There was no system malfunction found.No further action is warranted at this time.

Event Description

It was reported to siemens by the customer that a collision between the artiste mv treatment table and gantry occurred.The treatment tabletop was damaged.The collision occurred during manual movement of the treatment table a collision occurred between the left front part of the treatment table and the accessory-holder of the gantry (gantry position 180 degrees).The system asserted the motion stop.The customer stated that this issue was a due to user error.There was no injury to a patient or other persons.In a worst-case scenario, if the user does not pay attention during manual movement and has not verified collision clearance, this issue could lead to a collision situation in which the patient might sustain a severe bodily injury.As stated in the user manual always be aware that the automatic motion protection system (amp) is not active during manual movement of the gantry, the treatment table or the collimator.The reported event occurred in (b)(6).

• 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; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486484
• MDR Report Key: 10502882
• MDR Text Key: 206165246
• Report Number: 3002466018-2020-43955
• 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: Other
• Type of Report: Initial
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• 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: 08/26/2020
• 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