FDA Adverse Event
Malfunction
Summary report: N
XIO RTP SYSTEM
MDR report key: 538301
·
Received August 5, 2004
Report
- Report Number
- 1937649-2004-00003
- Event Type
- Malfunction
- Date Received
- August 5, 2004
- Date of Event
- June 2, 2004
- Report Date
- August 5, 2004
- Manufacturer
- COMPUTERIZED MEDICAL SYSTEMS, INC.
- Product Code
- KPQ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A CMS EMPLOYEE NOTED THAT WHEN A FIELD IS ENTERED ON A TEXT PAGE AND A POP-UP ERROR BOX IS DISPLAYED WHILE THE USER IS ENTERING INFO, IT IS POSSIBLE THAT THE VALUE STORED FOR THE FIELD WILL NOT MATCH WHAT THE USER ENTERED. THERE HAVE BEEN NO PT MISTREATMENTS AS A RESULT OF THIS BUG, AND NO CUSTOMERS HAVE REPORTED ENCOUNTERING THE PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XIO RTP SYSTEM | RADIATION TREATMENT PLANNING SYSTEM | KPQ | COMPUTERIZED MEDICAL SYSTEMS, INC. | ALL | 4.0.0-4.1.1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |