FDA Adverse Event
Malfunction
Summary report: N
VARIAN MEDICAL SYSTEM
MDR report key: 2268920
·
Received September 22, 2011
Report
- Report Number
- MW5022376
- Event Type
- Malfunction
- Date Received
- September 22, 2011
- Date of Event
- June 7, 2011
- Report Date
- September 22, 2011
- Manufacturer
- VARIAN MEDICAL SYSTEMS
- Product Code
- IYE
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
TWO PTS WERE SCHEDULED (BACK TO BACK) FOR RADIATION THERAPY FOR PROSTATE CANCER. FOR PT CONVENIENCE, THEY SWITCHED THEIR ORDER FOR TREATMENT. (B)(6) WAS TAKEN BACK TO THE TREATMENT AREA TO CHANGE CLOTHES AND THEN ENTERED THE TREATMENT ROOM. HIS NAME WAS BELOW THE OTHER PT ON THE SCREEN BUT THE TECH HIGHLIGHTED HIS NAME AND HIS PHOTO APPEARED. THE TECH USED THE MOUSE TO MOVE DOWN ON THE SCREEN TO THE "TREAT" BOX AND HE CLICKED ON THE "TREAT" BOX AND THE TREATMENT COMMENCED. THIS TOOK LESS THAN 1 SECOND. AT THE END OF THE TREATMENT, THE TECH NOTICED THAT THE NAME AND PICTURE ON THE SCREEN WERE OF THE FIRST PT WHO WAS SCHEDULED FOR RADIATION THERAPY, NOT THE PT WHO JUST COMPLETED THE TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VARIAN MEDICAL SYSTEM | LINEAR ACCELERATOR | IYE | VARIAN MEDICAL SYSTEMS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |