FDA Adverse Event
Summary report: N
BRILLIANCE EBW
MDR report key: 2583103
·
Received May 10, 2012
Report
- Report Number
- 1525965-2012-00022
- Date Received
- May 10, 2012
- Report Date
- April 13, 2012
- Manufacturer
- PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
- Product Code
- JAK
- PMA / PMN Number
- K012009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. AT THIS TIME. WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4). INITIAL MDR MAILED ON (B)(4) 2012.
Description of Event or Problem · 1
A PHILIPS APPLICATION SPECIALIST REPORTED THAT THE MANUAL HAS A POSSIBLE FORMULA ERROR ON THE LUMEN MEASUREMENTS. FOR CALCULATING THE DIFFERENCE BETWEEN LESION POINT AND REFERENCE POINT IN PERCENT, THE MANUAL SAYS "DIFFERENCE = (REFERENCE-LESION)/LESION" WHILE IT SHOULD BE "(REFERENCE-LESION)/REFERENCE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BRILLIANCE EBW | JAK | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. | 728260 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |