FDA Adverse Event
Malfunction
Summary report: N
CLINAC
MDR report key: 1163388
·
Received September 10, 2008
Report
- Report Number
- 2916710-2008-00041
- Event Type
- Malfunction
- Date Received
- September 10, 2008
- Date of Event
- August 11, 2008
- Report Date
- August 11, 2008
- Manufacturer
- VARIAN MEDICAL SYSTEMS
- Product Code
- IYE
- PMA / PMN Number
- K913119
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE, AS THIS MALFUNCTION, 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 GANTRY STOPPED ROTATING DURING TREATMENT DUE TO A LOOSE MOTOR DRIVE ASSEMBLY CAUSING THE GANTRY CHAIN TO SLIP OFF. THERE WERE NO INJURIES INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLINAC | LINEAR ACCELERATOR | IYE | VARIAN MEDICAL SYSTEMS | CL-IX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |