FOCAL WORKSTATION Adverse Event — Report (MDR 1937649-2008-00001)
FOCAL WORKSTATION Adverse Event — Report (MDR 1937649-2008-00001) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: FOCAL WORKSTATION; Generic name: RTP WORKSTATION; Manufacturer: CMS INC.
| Device | FOCAL WORKSTATION |
|---|---|
| Generic name | RTP WORKSTATION |
| Manufacturer | CMS INC |
| Report number | 1937649-2008-00001 |
| Product problem | N |
| Date received | 2008-02-15 |
| Report source | Health Professional, User facility |
| Narrative | A CUSTOMER REPORTED THAT A PATIENT BEING TREATED FOR LUNG CANCER HAD BEEN TREATED FOR 5 FRACTIONS WITH AN INCORRECT ISOCENTER (5 CM ERROR). THE ISOCENTER ERROR WAS INTRODUCED BY AN IMPORT APPLICATION PROBLEM IN FOCAL. HOWEVER, THE ERROR IS HIGHLY DETECTABLE AND IN THIS CASE, THE XIO VISUAL DISPLAY CLEARLY ALERTED DOSIMETRY TO THE PROBLEM. BASED ON CUSTOMER INPUT, THE INFORMATION LEAVING DOSIMETRY |
| Source | openFDA MAUDE (device adverse events) |
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