MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. PRIMUS HI; ACCELERATOR, LINEAR, MEDICAL

Model Number 04504200

Device Problems Device Operates Differently Than Expected (2913); Human-Device Interface Problem (2949)

Patient Problem No Patient Involvement (2645)

Event Date 03/20/2014

Event Type  malfunction  

Event Description

Siemens was notified on (b)(4) 2014 that the customer was experiencing mode interlock issues on the linac machine.Beam profile measurements were out of specification after a service task that was performed by the customer.Reportedly, if the beam profile deviates from the baseline, which is considered for treatment planning by the treatment planning system (tps), it would be possible for patients to receive an incorrect dose distribution resulting in adverse side effects or unsuccessful treatment.However, there is no report of patient injury or mistreatment.This reported issue occurred in (b)(6).

Manufacturer Narrative

Siemens was notified of the reported issue on (b)(4) 2014 and this mdr is being mailed on (b)(4) 2014.Siemen's investigation is on-going and a supplemental report will be submitted upon completion of the investigation.Customer address: (b)(6).

• Brand Name: PRIMUS HI
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 51 valley stream pkwy.; ms d02; malvern PA 19355
• Manufacturer (Section G): SIEMENS MEDICAL SOLUTIONS USA, INC.
• Manufacturer Contact: marlynne galloway ; 51 valley stream pkwy.; ms do2; malvern, PA 19355 ; 6102195361
• MDR Report Key: 3937345
• MDR Text Key: 22142386
• Report Number: 2910081-2014-02599
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K123812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04504200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2014
• 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: SW VERSION - V9.2.18; HW/FW LEVEL - ACTV