FDA Adverse Event
Summary report: N
BRILLIANCE 64
MDR report key: 2890919
·
Received December 21, 2012
Report
- Report Number
- 1525965-2012-00126
- Date Received
- December 21, 2012
- Report Date
- December 9, 2012
- Manufacturer
- PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
- Product Code
- JAK
- PMA / PMN Number
- K033326
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TC
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).
Description of Event or Problem · 1
PHILIPS RECEIVED A REPORT THAT THE CUSTOMER PERFORMED HEAD SCANS ON PTS AND REPORTED A SHADING ARTIFACT IN SOME IMAGES THAT COULD LEAD TO MISINTERPRETATION OF THESE IMAGES. PTS WERE RESCANNED ON AN MRI SYSTEM TO RULE OUT PATHOLOGY AND NO PTS WERE MISTREATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BRILLIANCE 64 | JAK | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. | 728231 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |