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

Model Number 8139789

Device Problem Unintended Movement (3026)

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

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

The initial reporter is a siemens employee.Initial reporter phone number is: (b)(6).Siemens has completed a technical investigation of the reported event.The root cause of the event was due to an issue with components of the vertical drive (converter and encoder).The siemens customer service engineer exchanged the converter, and encoder and the system was restored.No further action is warranted at this time.

Event Description

It was reported to siemens that the system treatment table (txt) dropped approximately 10 cm when it was being lowered.After the table had quickly dropped, the system asserted a motion stop, and the table stopped suddenly.There was no patient mistreatment, or injury to patient or user.In a worst-case scenario, if this event were to re-occur during patient treatment, the patient may be startled and could move and fall to the floor.This fall may result in a severe injury, which may necessitate medical treatment.This report is being submitted with an abundance of caution.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: 10895182
• MDR Text Key: 218692512
• Report Number: 3002466018-2020-53368
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• 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: 10/29/2020
• 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