MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AT-RO ONCOR IMPRESSION PLUS; ACCELERATOR, LINEAR, MEDICAL

Model Number 5857912

Device Problems Calibration Error (1078); Image Resolution Poor (1306); Calibration Problem (2890)

Patient Problems Radiation Overdose (1510); No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2016

Event Type  malfunction  

Manufacturer Narrative

Siemens' investigation is on-going and a supplemental report will be submitted upon completion.

Event Description

Siemens was notified on november 30, 2016 that the image quality on the oncor impression plus system was bad and siemens began servicing the system to resolve the issue.On march 13, 2017, the customer provided siemens with new information in regard to dose measurements of the affected system that clearly points to a mis-calibrated dose monitor system when using the film mode.The control console settings on the "low dose page" for 6 mv photons were checked and found to be incorrect.As a result, images for patient position verification using the film mode have been acquired with a higher dose than intended by the user.On march 14, 2017 the user was advised to discontinue the clinical use of the film mode and treatment techniques using the low dose page.The customer has reported that 50 patients have received a higher dose than intended during image acquisition however there is no report of injury.This reported issue occurred in (b)(6).

Manufacturer Narrative

The service engineer with the site physicist checked all modes.The low dose page and the film mode have been re-calibrated as of march 16, 2017.The user manual has been updated with detailed information with regards to the calibration of the film mode and has been distributed to the installed base.Considering this, no further corrective action is initiated.

• Brand Name: ONCOR IMPRESSION PLUS
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH AT-RO; medical solutions; roentgen strasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH AT-RO; medical solutions; roentgen strasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer Contact: marlynne galloway ; 40 liberty boulevard; mail stop 65-1a; malvern, PA 19355-9998 ; 6104486471
• MDR Report Key: 6479935
• MDR Text Key: 72675595
• Report Number: 2240869-2017-66642
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K060226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Service Personnel
• Type of Report: Initial,Followup
• Report Date: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5857912
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2006
• 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