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

Model Number 8162815

Device Problems Loss of Data (2903); Patient Data Problem (3197)

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

Event Date 10/04/2015

Event Type  malfunction  

Manufacturer Narrative

Siemens' investigation into the reported issue is on-going and a follow-up report will be submitted upon completion.Date of event has been requested.Model number has been requested.Initial reporter information has been requested.Customer address: (b)(6).

Event Description

The customer informed siemens on (b)(6) 2015 that they have the artiste stand alone system.According to the technicians, the system missed recording one session.They are sure that the patient was treated on (b)(6) 2015 (this was recorded manually to patient file by the technician), but when they printed the final report at rt therapist the report did not show that the patient was treated on that date.However, there is no report of mistreatment or injury to the patient.This reported issued occurred in (b)(6).

Manufacturer Narrative

Siemens' investigation findings indicates that the patient's treatment on (b)(6) 2015 was performed in quality assurance (qa) mode of rt therapist.In rt therapist 4.1, qa-mode records are also created and kept with the patient data but they do not refer dose.As such, they do not contribute to the final dose contribution records and they are not included in reports.When rt therapist is creating a qa record, it puts the qa record flag into the private attributes of such record and does not refer to any dose.The qa-mode is password-protected.The name of the user who entered the qa-mode has been identified in the provided logfiles.According to the available data, root cause for the issue is treatment having been performed in qa-mode.Considering this, no corrective action is initiated.

• Brand Name: SYNGO RT THERAPIST
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; medical solutions; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; medical solutions; roentgenstrasse 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: 5253616
• MDR Text Key: 32465739
• Report Number: 2240869-2015-25259
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K090683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial,Followup
• Report Date: 10/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8162815
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2016
• 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