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

Model Number 04503178

Device Problems Computer Operating System Problem (2898); Operating System Version or Upgrade Problem (2997)

Patient Problem No Patient Involvement (2645)

Event Date 04/25/2014

Event Type  malfunction  

Event Description

Siemens was informed on (b)(4) 2014 that the customer's lantis system is operating on windows 7, which is not validated to be used with lantis versions.Reportedly, the use of the windows 7 operating system with lantis versions may result in incorrectly stored data such as treatment records, and may also lead to lantis database corruption, which could cause patient mistreatment.There is no report of mistreatment or injury to a patient.

Manufacturer Narrative

Siemens' investigation into the reported issue has concluded that the operation system used by the customer is windows 7.Siemens does not support operating systems with higher windows versions than xp (with service pack 3).A field safety notice, under ui th013/14/s, was distributed to customer on 05/06/2014, warning them of possible safety risks when using more recent microsoft windows operating systems and that they must not be used with lantis.It is recommended that all computers with the lantis client software installed are running on an operating system that was validated by siemens for operation with lantis, e.G.Microsoft windows xp service pack 3 (sp3).

• Brand Name: LANTIS COMMANDER, 10 USERS
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 51 valley stream parkway; malvern PA 19355
• Manufacturer (Section G): SIEMENS MEDICAL SOLUTIONS USA, INC.
• Manufacturer Contact: marlynne galloway ; 51 valley stream parkway, ms-d02; malvern, PA 19355 ; 6102195361
• MDR Report Key: 3916346
• MDR Text Key: 4666137
• Report Number: 2910081-2014-03885
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04503178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2014
• 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
• Patient Sequence Number: 1
• Treatment: WINDOWS 7