MAUDE Adverse Event Report: SIEMENS HEALTHINEERS ADVANCED THERAPY ARTISTE MV SYSTEM; ACCELERATOR, LINEAR, MEDICAL

Model Number 8139789

Device Problems Misconnection (1399); Use of Device Problem (1670)

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

Event Date 07/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Siemens is conducting an investigation of the reported events.The investigation is on-going and a supplemental report will be filed should further information become available.Resubmission of initial report due to report code error.

Event Description

It was reported to siemens that a malfunction occurred with the artiste mv system.We are unaware of any impact to the state of health of any patient involved.

Manufacturer Narrative

Siemens completed an investigation of the reported event.The complaint malfunction is reproducible with the old style ((b)(4)) and new style ((b)(4)) leaf controller boards.The root cause was identified as being attributed to two of the leaf controller pcbs (d25 and d26) being incorrectly configured by the dip switches.One of the controllers controls the even leaves the other controls the odd leaves.In this case, the commands for odd leaves were sent to the even ones and vice versa in the range of leaf number x1.1 to x1.39.The actual field shape was incorrect in that area.No interlock has occurred.In these cases when the dip switch setting of d25 mixed up with the d26 or the d21 with d22 the system behaves in such way because no automatic identification is implemented.The remaining leaf controllers would report an error if they were swapped because those include a termination which is recognized.The associated risk was identified and mitigated by the request of verification of the leaf positions after servicing.The service documentation replacement of parts th02-160.841.01 841.01.16 incudes an explicit warning regarding verification of the dip switch setting and to perform leaf position accuracy tests.No systematic issue in the field was identified.The investigation showed also that there is no reasonable probability that the use of our product will cause serious adverse health consequences or death and that the use of our product will not cause temporary or medically reversible adverse health consequences, or an outcome where the probability of serious adverse health consequences is remote.The reported event occurred in france.

• Brand Name: ARTISTE MV SYSTEM
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHINEERS ADVANCED THERAPY; roentgenstrasse 19-21; kemnath 95478 ; GM 95478
• MDR Report Key: 8491103
• MDR Text Key: 146374273
• Report Number: 3002466018-2018-39614
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• PMA/PMN Number: K072485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/13/2018
• Initial Date FDA Received: 04/08/2019
• Supplement Dates Manufacturer Received: 02/06/2020
• Supplement Dates FDA Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1