FDA Adverse Event Malfunction Summary report: N

CLINAC

MDR report key: 1964112 · Received December 20, 2010

Report

Report Number: 2916710-2010-00148
Event Type: Malfunction
Date Received: December 20, 2010
Date of Event: November 22, 2010
Report Date: November 22, 2010
Manufacturer: VARIAN MEDICAL SYSTEMS
Product Code: IYE
PMA / PMN Number: K070094
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE, AS THIS EVENT, 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

THE THERAPISTS TREATED THE FIRST FIELD AS EXPECTED AND THEN A SECOND FIELD THAT HAD THE SAME GANTRY ANGLE BUT A DIFFERENT ENERGY WAS MODED UP. WHEN THE THERAPIST PRESSED THE MOTION ENABLE THE GANTRY STARTED TO ROTATE UNEXPECTEDLY. ONCE THEY LET GO OF THE MOTION ENABLE BUTTONS AND THEN RESELECTED THE MOTION ENABLE BUTTONS THE GANTRY MOVED BACK TO THE ORIGINAL ANGLE THAT WAS PLANNED FOR THE FIELD. ON A DIFFERENT PATIENT THAT DAY THE COLLIMATOR ALSO ROTATED UNEXPECTEDLY FROM 0 TO 2.5 DEGREES WHILE THE GANTRY WAS MOVING FROM 0 TO 270 BETWEEN 2 FIELDS. GANTRY STARTED ROTATING UNEXPECTEDLY ON 1 PATIENT. COLLIMATOR STARTED ROTATING UNEXPECTEDLY ON 1 PATIENT. THESE 2 PATIENTS HAVE BEEN MONITORED DAILY AND THE ISSUE HAS NOT OCCURRED AGAIN WITH THESE PATIENTS OR ANY OTHERS. THIS ISSUE IS NOT REPRODUCIBLE AT SITE. THE CHIEF PHYSICIST ACKNOWLEDGES THAT IT IS POSSIBLE THAT THE WRONG KEYS WERE PRESSED ON THE DEDICATED KEYBOARD BUT SINCE THE THERAPISTS FEEL THIS WASN'T THE CASE HE WOULD LIKE THE ISSUE INVESTIGATED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CLINAC	LINEAR ACCELERATOR	IYE	VARIAN MEDICAL SYSTEMS	H27

Patients

Seq	Age	Sex	Outcome	Treatment
1