FDA Adverse Event Malfunction Summary report: N

TOMOEDGE TREATMENT SYSTEM

MDR report key: 6663977 · Received June 23, 2017

Report

Report Number: 3003873069-2017-00008
Event Type: Malfunction
Date Received: June 23, 2017
Date of Event: May 25, 2017
Report Date: May 25, 2017
Manufacturer: ACCURAY INCORPORATED
Product Code: IYE
PMA / PMN Number: K121934
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE BRAKING RESISTOR BOARD, VDA ACTUATOR, BRB TO SERVO AMP CABLE AND VDA SERVOSTAR WERE RETURNED AND PENDING ANALYSIS ON THE DAY OF THIS REPORT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE COUCH WOULD NOT MOVE IN THE Z-AXIS WHEN THE USER ATTEMPTED TO CONTROL IT FROM THE COUCH CONTROL KEYPAD (CCK). HOWEVER, WHEN THE POSITIONING CONTROL PANEL (PCP) WAS USED IT MOVED IN THE VERTICAL DIRECTION WITH UNUSUAL NOISE. ACCURAY SUPPORT INSPECTED THE BRAKING RESISTOR BOARD (BRB) AND CABLES. NO BURNT MARKS OR BAD CONNECTIONS WERE DISCOVERED. THE VERTICAL DRIVE ASSEMBLY (VDA), BRB, AND BOTH CABLES FROM THE VDA TO SERVO STAR WERE REPLACED. ACCURAY SUPPORT ALSO REPLACED THE BATTERY PACK, CALIBRATED AND TESTED THE COUCH WITH NO ERROR. UPON FOLLOW-UP FIELD PERSONNEL INDICTED THAT THERE WAS 10-15CM OF UNEXPECTED Z AXIS MOVEMENT. WHEN TRYING TO MOVE THE COUCH FOR THE 5 MINUTE WARM-UP FROM THE UNLOAD POSITION, IT DESCENDED AFTER MOVING 3MM IN THE POSITIVE Z. NO PATIENT WAS ON THE COUCH. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
443680	TOMOEDGE TREATMENT SYSTEM	TOMOTHERAPY TREATMENT SYSTEM	IYE	ACCURAY INCORPORATED	1018286

Patients

Seq	Age	Sex	Outcome	Treatment
1