MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. LANTIS COMMANDER,10 USERS; ACCELERATOR, LINEAR, MEDICAL

Model Number 4503178

Device Problem Programming Issue (3014)

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

Event Date 02/01/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation into the reported issue has revealed that the affected user installed windows server 2008 operating system while running on lantis server software, which is an invalid configuration.Siemens distributed a customer advisory notice (th023/14/s) dated january 21, 2015, informing all users that running lantis server software with operating systems higher than microsoft windows server 2003 is not a valid configuration and might lead to incorrectly stored data and/or loss of data.Siemens received the customer's signed acknowledgement for this customer advisory notice and it is available on file.There have been no similar issues reported.Considering this, no corrective action is initiated.Customer address: (b)(6).

Event Description

Siemens was notified on february 1, 2016 that the customer had installed an invalid configuration using windows server 2008r2 operating system while running on lantis server software.Reportedly, several software re-registration attempts were made without success.However, no data corruption or loss was reported.There has been no injury or mistreatment to a patient reported.This reported issue occurred in (b)(6).

• Brand Name: LANTIS COMMANDER,10 USERS
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; radiation oncology; 4040 nelson avenue; concord CA 94520
• 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: 5438489
• MDR Text Key: 38862441
• Report Number: 2240869-2016-32266
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: BU
• PMA/PMN Number: K972275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Service Personnel
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service Personnel
• Device Model Number: 4503178
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2240869-01/23/2015-0004
• Patient Sequence Number: 1