MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH COHERENCE ONCOLOGIST; ACCELERATOR, LINEAR, MEDICAL

Model Number 7333680

Device Problem Image Orientation Incorrect (1305)

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

Event Date 08/06/2019

Event Type  malfunction  

Manufacturer Narrative

Reporter phone number is siemens representative (b)(6).All relevant image transformation data must be applied to the image before it is displayed.Siemens released a mandatory software upgrade via ui th018/08/s in 2008 to resolve the reported issue.This update was not applied to the reported system.The absence of this software update is the root cause of the reported issue.It is unknown at this time why the update was not applied to the complaint system.If additional information is obtained, it will be provided in a supplemental report.

Event Description

It was reported to siemens that after applying clahe (contrast-limited adaptive histogram equalization), an application in the component, coherence oncologist, the image shifts left and up.The calculated offsets also differ.The problem occurs during all patient treatments.The number of events is unknown.The issue is not reproducible.There was no report of patient injury or mistreatment.Due to this issue, the customer decided not to use clahe.If after the portal image filtering, the image is not displayed at the correct location and mistreatment due to dose to wrong location could occur and could lead to serious bodily injury.All relevant image transformation data must be applied to the image before it is displayed.The reported event occurred in (b)(6).

• Brand Name: COHERENCE ONCOLOGIST
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; doris ruppenstein str; erlangen, 90152 ; GM 90152
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486484
• MDR Report Key: 8955420
• MDR Text Key: 216764914
• Report Number: 3002466018-2019-93168
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K060633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/07/2019

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: 7333680
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 09/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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