MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC., RADIATION ONCOLOGY MOSAIQ; ACCELERATOR, LINEAR, MEDICAL

Model Number 10568605

Device Problem Patient Data Problem (3197)

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

Event Date 12/21/2013

Event Type  Other  

Event Description

The customer notified siemens on (b)(6) 2013 that when a cone beam acquisition is taken on the artiste system with syngo rt therapist 4.3, the acquisition for the pt is transferred to mosaiq.Then, the image review process is done with the internal auto registration of mosaiq (mmi) and the initial region of interest shows up with different values than those that were in syngo rt therapist.Reportedly, the customer is not able to modify the size of the region of interest for several patients.There are no reports of mistreatment or injury to a pt.This reported issue occurred in (b)(6).

Manufacturer Narrative

Siemens became aware of the reported issue on (b)(6) 2013.Siemens' investigation into the reported issue is on-going.A supplemental report will be submitted to the fda upon completion of the investigation.(b)(6).

• Brand Name: MOSAIQ
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC., RADIATION ONCOLOGY; 757a arnold drive; martinez CA 94553
• Manufacturer (Section G): SIEMENS MEDICAL SOLUTIONS USA, INC.; 757a arnold drive; martinez CA 94553
• Manufacturer Contact: marlynne galloway ; 51 valley stream parkway; ms-d02; malvern, PA 19355 ; 6102195361
• MDR Report Key: 3608293
• MDR Text Key: 4172785
• Report Number: 2910081-2014-11666
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/21/2013

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: 10568605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2013
• Initial Date FDA Received: 01/21/2014
• 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: SYNGO RT THERAPIST, 4.3; SW VERSION V2.41.01H2