FDA Adverse Event
Malfunction
Summary report: N
MLP SYSTEM
MDR report key: 80479
·
Received March 26, 1997
Report
- Report Number
- 1217116-1997-00015
- Event Type
- Malfunction
- Date Received
- March 26, 1997
- Date of Event
- February 21, 1997
- Report Date
- February 21, 1997
- Manufacturer
- PHILLIPS MEDICAL SYSTEMS RADIOTHERAPY
- Product Code
- IYE
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
DURING APPLICATION TRAINING, IT WAS DISCOVERED THAT THE FOREIGN LANGUAGE VERSIONS OF THE PRESCRIPTION SYSTEM CAN INCORRECTLY CONVERT THE CAMERA SCALING FACTORS USED WHEN PLANNING MULTI-LEAF POSITION VALUES FOR EXPORT TO THE COLLIMATOR SYSTEM. THE COLLIMATOR SYSTEM DEFINED TREATMENT FIELD FOR THE SL SERIES OF LINEAR ACCELERATORS. CAMERA SCALING FACTORS TO 1.00 TO 1.05 ARE INCORRECTLY TRUNCATED TO 1.00 RESULTING IN A POSSIBLE MAXIMUM MULTI-LEAF COLLIMATOR POSITION ERROR OF 5%. ALLEGEDLY, THIS WILL RESULT IN AN UNDERDOSE TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MLP SYSTEM | LINEAR ACCELERATOR PRESCRIPTIN ENTRY SYSTEM | IYE | PHILLIPS MEDICAL SYSTEMS RADIOTHERAPY | MLP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |