MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH, ADVANCED THERAPIES ONCOR AVANT GARDE; ACCELERATOR, LINEAR, MEDICAL

Model Number 7346534

Device Problems Display or Visual Feedback Problem (1184); Use of Device Problem (1670)

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

Event Date 06/27/2018

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting an investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplemental report will be submitted when the examination is completed should further information become available.

Event Description

It was reported to siemens on (b)(6) 2018, that a malfunction occurred while operating the oncor avant garde system during qa with out any patient involved.The user detected the incorrect display of the vertical table coordinate prior to patient treatments.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.On the day of the occurrence there was error "7200" logged on the table vertical axis in txt550 table error log.The error "7200" is set if a jump has been detected on the absolute encoder value.The error corresponds to the customer observation e.G.5,2 cm was displayed at the table zero position.The error may occur if the encoder aging and has recoverable radiation damages.In case of occurrence the table must be calibrated.This was identified as the root cause of the complaint issue.It is recommended to replace the concerned encoder when this issue arises.The vertical encoder was replaced.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.No further action is warranted at this time.

• Brand Name: ONCOR AVANT GARDE
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH, ADVANCED THERAPIES; roentgenstrasse 19-21; kemnath, germany 95478 ; GM 95478
• MDR Report Key: 8491533
• MDR Text Key: 143968246
• Report Number: 3002466018-2018-37106
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• PMA/PMN Number: K031764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7346534
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1