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

Model Number 5857912

Device Problem Operating System Version or Upgrade Problem (2997)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation is on-going and a supplemental report will be submitted upon completion.

Event Description

Siemens was notified on (b)(6) 2017 that the imaging feature is not available after the linac system received a software update.It was reported that when the rt therapist was upgraded to 4.3.1_mr3, the control console upgrade to 13.302 was not performed as required.The system is now running a non-validated software combination without the control console upgrade, which is the cause for the imaging feature being unavailable.The customer was advised to stop treatments on the linac until either the control console is updated or the rt therapist is downgraded.There is no report of injury or mistreatment to a patient.This reported issue occurred in (b)(6).

• 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: 6585266
• MDR Text Key: 75774415
• Report Number: 3002466018-2017-79815
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 05/22/2017,05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5857912
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/22/2017
• Distributor Facility Aware Date: 05/08/2017
• Device Age: 11 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2017
• Date Manufacturer Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: No
• 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