FDA Adverse Event Malfunction Summary report: N

ECLIPSE

MDR report key: 2475752 · Received January 31, 2012

Report

Report Number: 3003793371-2008-00016
Event Type: Malfunction
Date Received: January 31, 2012
Date of Event: November 21, 2008
Report Date: November 21, 2008
Manufacturer: VARIAN MEDICAL SYSTEMS
Product Code: MUJ
PMA / PMN Number: K073020
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

THE INVESTIGATION REVEALED THAT WHEN A PLAN REVISION IS CREATED AND THE SSD (SOURCE SURFACE DISTANCE) IS CHANGED, AND THE REVISED PLAN IS APPROVED VIA RT CHART, THE ACTUAL SSD VS PLANNED SSD IS NOT DISPLAYED TO THE USER DURING APPROVAL, NOR IS THE IN-ROOM DISPLAY SSD UPDATED WITH THE NEW PLANNED SSD. THE IN-ROOM DISPLAY IS THEN USED FOR PT TREATMENT SET-UP AT DIFFERENT DISTANCE THAN CALCULATED. THIS SCENARIO COULD RESULT IN A TREATMENT OVERDOSE OR UNDER DOSE, DEPENDENT UPON THE PLANNED VS TREATED DISTANCE. A PRODUCT NOTIFICATION LETTER WAS SENT TO AFFECTED CUSTOMERS. ALL CORRECTIVE ACTION WILL BE REPORTED UNDER THE GUIDELINES OF 21 CFR PART 806. NO FOLLOW-UP REPORTS ARE ANTICIPATED. (B)(4).

Description of Event or Problem · 1

CUSTOMER CALLED BECAUSE THEY COPIED A PLAN THAT ORIGINALLY HAD AN SSD OF 110CM WHICH WAS MODIFIED TO CHANGE THE ISOCENTER WITH A NEW SSD OF 102CM. CUSTOMER PRINTED THE REPORT, AND THE ACTUAL SSD WAS STILL 110CM. CUSTOMER WANTED TO KNOW WHY. NO PT INJURY REPORTED, AND NO PT DATA PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ECLIPSE	TREATMENT PLANNING SYSTEM	MUJ	VARIAN MEDICAL SYSTEMS	H48

Patients

Seq	Age	Sex	Outcome	Treatment
1