FDA Adverse Event
Malfunction
Summary report: N
ONCENTRA MASTERPLAN
MDR report key: 1076851
·
Received July 14, 2008
Report
- Report Number
- 9611894-2008-00012
- Event Type
- Malfunction
- Date Received
- July 14, 2008
- Date of Event
- June 23, 2008
- Report Date
- July 10, 2008
- Manufacturer
- NUCLETRON B.V.
- Product Code
- MUJ
- PMA / PMN Number
- K081281
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS PROBLEM IS THE SAME AS THE PROBLEMS REPORTED UNDER 9611894-2008-00007 THROUGH 961184-2008-00011. CUSTOMER BULLETIN 555.00072-01 REVISED INFORMATION: INCONSISTENT DOSE AFTER BEAM WEIGHTING OR AUTO RECOVERY WAS RE-ISSUED TO FACILITIES ON JUNE 24, 2008. IN ADDITION, SERVICE BULLETIN 666.00020-00, STOP ROLL-OUT OF ONCENTRA MASTERPLAN FOR ALL EXTERNAL BEAM CUSTOMERS WAS ISSUED ON JUNE 24, 2008.
Description of Event or Problem · 1
NO ISODOSE REFRESHING AFTER BEAM WEIGHTING TOOL IS USED TO MODIFY MOTORIZED WEDGE CONTRIBUTION. MU'S DO NOT REFRESH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONCENTRA MASTERPLAN | MEDICAL CHARGED PARTICLE RADIATION THER | MUJ | NUCLETRON B.V. | 170.700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |