FDA Adverse Event
Malfunction
Summary report: N
BRILLIANCE BIG BORE
MDR report key: 2169506
·
Received July 8, 2011
Report
- Report Number
- 1525965-2011-00034
- Event Type
- Malfunction
- Date Received
- July 8, 2011
- Report Date
- June 13, 2011
- Manufacturer
- PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
- Product Code
- JAK
- PMA / PMN Number
- K033357
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INVESTIGATION INTO THE COMPLAINT HAS REVEALED THAT THE ROOT CAUSE OF THE MALFUNCTION IS A SOFTWARE DEFECT. THE DEFECT WILL BE RESOLVED BY MAKING APPROPRIATE CHANGES TO THE TUMOR LOC SOFTWARE. THE AFFECTED CUSTOMERS WILL RECEIVE THE UPDATED SOFTWARE.
Description of Event or Problem · 1
PHILIPS REC'D A COMPLAINT STATING THAT A SOFTWARE MALFUNCTION CAUSED THE COLOR FOR CONTOURS IN A BEAM'S EYE VIEW (BEV) IN A TREATMENT PLAN OF THE TUMORLOC APPLICATION TO CHANGE WHEN BEV DISPLAY IS TURNED OFF FOR THE EXTERNAL CONTOUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BRILLIANCE BIG BORE | JAK | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. | 728243 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |