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

Model Number 8139789

Device Problem Data Problem (3196)

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

Event Date 01/30/2017

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report due to report error.The original initial report was submitted on 04/6/2017 as mfr report #2240869-2017-69043.This report also replaces mfr report #3002466018-2019-69043, which was submitted in error with the wrong report #.Siemens has initiated a technical investigation of the reported event.A root cause has not yet been identified.A supplemental report will be filed upon the completion of the investigation.The reported event occurred in (b)(4).

Event Description

The customer informed siemens on (b)(6) 2017 that after moving different translational table axis, the rotational value of the column axis was incorrect by 0.8 degrees.The user confirmed that only the value on the display changed from 0.0 degrees to 0.8 degrees however the actual table position was at 0.0 degrees.It is reported that this was a single event for one patient and there is no report of injury or mistreatment as the user recognized the deviation of the display value and the value of the actual table position.This reported event occurred in (b)(4).

• Brand Name: ARTISTE MV SYSTEM
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; roentgen strasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; roentgen strasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486484
• MDR Report Key: 8565079
• MDR Text Key: 145514878
• Report Number: 3002466018-2017-69043
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/31/2017

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?: 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: 01/31/2017
• Was Device Evaluated by Manufacturer?: No
• 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