FDA Adverse Event
Malfunction
Summary report: N
TX NOVALIS
MDR report key: 1944593
·
Received December 13, 2010
Report
- Report Number
- 1944593
- Event Type
- Malfunction
- Date Received
- December 13, 2010
- Date of Event
- November 9, 2010
- Report Date
- December 13, 2010
- Manufacturer
- VARIAN MEDICAL SYSTEMS, INC.
- Product Code
- IYE
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- ME, US
Narratives
Description of Event or Problem · 1
A WATER HOSE CATCHES AS THE GANTRY ROTATES AND COMES OFF ALL AT ONCE CAUSING A WATER HAMMER THAT IS PICKED UP BY THE FLOW DETECTORS AND CREATING A FLOW FAULT. THE TX LINEAR ACCELERATOR CANNOT TREAT PATIENTS THAT WAY SO VARIAN ENGINEERS HAD US BYPASS ALL 4 FLOW DETECTORS UNTIL THE NEW PARTS ARRIVED. VARIAN CHANGED IT LAST NIGHT AND ALL SEEMS WELL SO FAR.======================HEALTH PROFESSIONAL'S IMPRESSION======================WATER HOSE COULD HAVE CAUGHT THE GANTRY AND BROKEN OPEN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TX NOVALIS | LINEAR ACCELERATOR, RADIOTHERAPY UNIT | IYE | VARIAN MEDICAL SYSTEMS, INC. | TX NOVALIS | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |