MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH, ADVANCED THERAPIES SYNGO RT THERAPIST; ACCELERATOR, LINEAR, MEDICAL

Model Number 8162815

Device Problems Use of Device Problem (1670); Data Problem (3196)

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

Event Date 04/29/2018

Event Type  malfunction  

Manufacturer Narrative

Siemens was told by the user that they performed a full geometrical calibration of the machine during april 2018.After the recalibration the matching was improved but sporadically they have seen negligible discrepancies with regard to the reticle again.Investigation is on-going and a supplemental report will be submitted should further information become available.Resubmission of initial report due to report code error.

Event Description

It was reported to siemens on (b)(6) 2018, that a malfunction occurred while operating the syngo rt therapist.When the operator was performing the qa plan with a phantom, on image review they sporadically observed discrepancies between the machine isocenter and laser and imager.When the user was loading a reference image they noted that the green reticle does not match exactly the isocenter of the reference range; therefore, also the portal image did not match the isocenter.No injury or mistreatment to a patient has been reported.

Manufacturer Narrative

Siemens completed the investigation of the reported event.The root cause of the reported isocenter shift between the drrs and the portal images could not be determined.The event might be attributed to the unfortunate summing of minor deviations below the threshold at different sub-components or it may be attributed to wear and tear.No systematic issues were discovered.The room lasers were adjusted.A star shot was verified with different blds to exclude eventual mechanical looseness of carriage/jaw.The gantry was recalibrated especially with respect to the 180-degree cw and ccw positions being captured identically.No further action is warranted at this time.

• Brand Name: SYNGO RT THERAPIST
• 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: 8491534
• MDR Text Key: 146374270
• Report Number: 3002466018-2018-35807
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• PMA/PMN Number: K102671
• 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: 06/19/2018

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: 8162815
• 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