FDA Adverse Event
Summary report: N
BRILLIANCE 16 WATER
MDR report key: 3121619
·
Received May 15, 2013
Report
- Report Number
- 1525965-2013-00120
- Date Received
- May 15, 2013
- Report Date
- April 16, 2013
- Manufacturer
- PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
- Product Code
- JAK
- PMA / PMN Number
- K012009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- 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 F/U MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).
Description of Event or Problem · 1
PHILIPS REC'D A REPORT WHERE A CUSTOMER STATES THE SYSTEM "DISPLAYS AN ARTIFACT." THERE IS NO REPORT OF RESCAN, MISINTERPRETATION, OR MISTREATMENT OF A PT DUE TO THIS REPORTED ISSUE. NO ADD'L INFO IS AVAILABLE REGARDING THIS CUSTOMER ALLEGATION AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 214499 | BRILLIANCE 16 WATER | JAK | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. | 728245 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |