FDA Adverse Event Malfunction Summary report: N

MEVATRON KD-2

MDR report key: 964963 · Received December 12, 2007

Report

Report Number: 2910081-2007-00025
Event Type: Malfunction
Date Received: December 12, 2007
Date of Event: August 27, 2007
Report Date: August 27, 2007
Manufacturer: SIEMENS MEDICAL SOLUTIONS OCS
Product Code: IYE
PMA / PMN Number: K862339
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

EVALUATION SUMMARY: ATTACHMENT 1 - RISK ANALYSIS EXCERPTS. ATTACHMENT 2 - TEST DATA. ATTACHMENT 3 - UPDATE INSTRUCTIONS/ CUSTOMER ADVISORY LETTER. CATALOG NUMBER FOR THE LINEAR MEDICAL ACCELERATORS: 9411588, 9822685, 9822693, 1940753, 1940035, 4504200, 5857912.

Description of Event or Problem · 1

IN ABUNDANCE OF CAUTION THIS ISSUE IS BEING REPORTED. SIEMENS MEDICAL SOLUTIONS HAS BECOME AWARE OF AN ISSUE WITH AN APPLICATOR ASSEMBLY THAT IS USED ON OUR LINEAR MEDICAL ACCELERATOR. AS A RESULT OF A RECENT INTERNAL AUDIT/INVESTIGATION, WE DETERMINED THAT THE DIGITAL ELECTRON VARIABLE APPLICATOR IS COMPLIANT WITH IEC WITH EXCEPTION OF THE RADIATION LEAKAGE AT A DISTANCE OF 2CM FROM THE SITE OF THE APPLICATOR BODY IN COMBINATION WITH FIELD SIZES OF 5CM X 5CM OR SMALLER. THE IEC ALLOWS A MAXIMUM LEAKAGE OF 10% AT 2CM FROM THE SITE OF THE APPLICATOR BODY. THE MAXIMUM MEASURED LEAKAGE VALUE ON A SIEMENS LINEAR ACCELERATOR AT 6MEV WAS 13% (4CM X 4CM FIELD SIZE). FOR THE 5CM X 5CM FIELD THE MEASURED VALUE WAS 11.4%. SIEMENS IS MAKING ITS AFFECTED CUSTOMERS AWARE OF THIS SITUATION SO THAT THEY CAN TAKE THIS INTO ACCOUNT WHEN TREATING PATIENTS WITH THIS COMBINATION OF ENERGY AND FIELD SIZES. IN RESPONSE, UPDATE INSTRUCTION/ADVISORY LETTER HAS BEEN RELEASED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MEVATRON KD-2	ACCELERATOR, LINEAR, MEDICAL	IYE	SIEMENS MEDICAL SOLUTIONS OCS	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	YR