FDA Adverse Event
Malfunction
Summary report: N
4D INTEGRATED TREATMENT CONSOLE
MDR report key: 1960769
·
Received December 17, 2010
Report
- Report Number
- 2916710-2010-00143
- Event Type
- Malfunction
- Date Received
- December 17, 2010
- Date of Event
- December 9, 2010
- Report Date
- December 9, 2010
- Manufacturer
- VARIAN MEDICAL SYSTEMS
- Product Code
- LHN
- PMA / PMN Number
- K002194
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE, AS THIS MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE A SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THERAPISTS REPORTED A "SAVE OF SESSION DATA AND/OR TREATMENT RECORDS FAILED" WARNING ON THE 4DITC ON (B)(6) ON MACHINE (B)(4). DIRECTOR OF PHYSICS LOCATED THE FILES FROM THE BACKUP FOLDER AND ATTEMPTED TO IMPORT THEM INTO RTCHART. HE NOTED THAT ONLY 2 OF THE 3 FILES IMPORTED INTO RTCHART HISTORY. HE THEN CALLED THE HELPDESK FOR ASSISTANCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4D INTEGRATED TREATMENT CONSOLE | LINEAR ACCELERATOR SOFTWARE | LHN | VARIAN MEDICAL SYSTEMS | H51-TREAT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |