FDA Adverse Event Malfunction Summary report: N

ACUITY

MDR report key: 1991514 · Received January 28, 2011

Report

Report Number: 8020711-2010-00011
Event Type: Malfunction
Date Received: January 28, 2011
Date of Event: October 20, 2010
Report Date: October 20, 2010
Manufacturer: VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS
Product Code: KPQ
PMA / PMN Number: K023052
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PO
Reporter Occupation: PHYSICIST

Narratives

Additional Manufacturer Narrative · 1

ALTHOUGH THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFORMATION SUGGESTS A MALFUNCTION OF THE DEVICE MAY HAVE OCCURRED. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE AS THIS MALFUNCTION AND RESULTING SMALL FLAME, SHOULD IT RECUR, COULD POTENTIALLY CAUSE A SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem · 1

PATIENT WITH 2 RTCHART PLANS - 1ST PLAN APPROVED, 2ND PLAN (BOOST) NOT APPROVED AND PLANNED NUMBER OF FRACTIONS CHANGED FROM 23 TO 43. DAYS BEFORE STARTING THE 2ND PLAN AT FRACTION NO 20, THE PATIENT WAS SIMULATED AGAIN FOR FIELD VERIFICATION. AN IMAGE FOLDER WAS CREATED INSIDE THE 1ST PLAN AND NO ADDITIONAL CHANGES WERE MADE. UPON OPENING THE PATIENT PLAN ON THE ECLIPSE SYS. THE CUSTOMER RECEIVED A WARNING MESSAGE AND FOUND THAT THERE WERE 2 PLANS WITH THE SAME ID, THE FORMER PLAN AND THE ORIGINAL PLAN. IN RTCHART, THE CUSTOMER HAD ONE PLAN WITH 43 FRACTIONS INSTEAD OF 23. UPON LOOKING CLOSER AT THE RTCHART EDITING LOG, THERE WAS FOUND A TREAT APPROVAL FOR A USER THAT HAD NO TREATMENT APPROVAL RIGHTS. THERE WAS NO MISADMINISTRATION OR SERIOUS INJURY REPORTED ASSOCIATED WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACUITY	SYSTEM, STIMULATION, RADIATION THERAPY	KPQ	VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS	H77

Patients

Seq	Age	Sex	Outcome	Treatment
1