FDA Adverse Event
Malfunction
Summary report: N
MONACO RTP SYSTEM
MDR report key: 3862914
·
Received February 20, 2014
Report
- Report Number
- 1937649-2014-00004
- Event Type
- Malfunction
- Date Received
- February 20, 2014
- Report Date
- February 20, 2014
- Manufacturer
- IMPAC MEDICAL SYSTEMS, INC
- Product Code
- MUJ
- PMA / PMN Number
- K110730
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUSPECT MEDICAL DEVICE: MONACO 5.00.00.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN A CONE IS USED IN COMBINATION WITH BEAM MODULATOR, THE MLC SHOULD SNAP TO THE CONE SIZE. HOWEVER, WHEN A BEAM IS COPIED, THE MLC IS EXPANDING BACK TO THE OPEN 16X21 FIELD SIZE. THE INTENDED STEREOTACTIC TREATMENT WOULD BE COVERING A FIELD POTENTIALLY MUCH LARGER THAN INTENDED. THERE WAS NO MISTREATMENT. THIS ISSUE WAS FOUND INTERNALLY, DURING AD HOC TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 106721 | MONACO RTP SYSTEM | RADIATION TREATMENT PLANNING SYSTEM | MUJ | IMPAC MEDICAL SYSTEMS, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |