FDA Adverse Event
Malfunction
Summary report: N
HI - ART SYSTEM
MDR report key: 1486704
·
Received August 11, 2009
Report
- Report Number
- 3003873069-2009-00001
- Event Type
- Malfunction
- Date Received
- August 11, 2009
- Date of Event
- July 17, 2009
- Report Date
- August 11, 2009
- Manufacturer
- TOMOTHERAPY INCORPORATED
- Product Code
- IYE
- PMA / PMN Number
- K060912
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DESIGN ANOMALY IN SW 2.4 AND 3.XX. URGENT MEDICAL DEVICE NOTIFICATION. EVALUATION TO BE PROVIDED IN FOLLOW-UP REPORT.
Description of Event or Problem · 1
DURING RADIATION TREATMENT, THE THERAPIST NOTED THAT THE USUAL DATA OF TREATMENT (DOSE RATE, MU'S, COUCH POSITION UPDATES OR PROCEDURE TIME) WERE NOT VISIBLE ON THE OS DISPLAY, EVEN THOUGH THE RAD ON INDICATORS WERE ACTIVE. THE TREATMENT WAS THEN STOPPED AT APPROXIMATELY THE 4 MINUTE MARK, BUT THE SYSTEM DID NOT MARK THE TREATMENT AS INTERRUPTED. WHEN THE TREATMENT WAS RE-RUN, INSTEAD OF IT STARTED AT THE APPROXIMATELY 4 MINUTE MARK, THE ENTIRE TREATMENT WAS DELIVERED. THE PATIENT RECEIVED THE FIRST APPROXIMATELY 4 MINUTES OF THE TREATMENT TWICE. THE CUSTOMER CONFIRMED THIS EVENT DID NOT RESULT IN PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HI - ART SYSTEM | IYE AND MUJ | IYE | TOMOTHERAPY INCORPORATED | H-0000-0003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |