FDA Adverse Event
Summary report: N
BRILLIANCE EBW
MDR report key: 2112469
·
Received March 22, 2011
Report
- Report Number
- 1525965-2011-00016
- Date Received
- March 22, 2011
- Report Date
- February 21, 2011
- Manufacturer
- PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
- Product Code
- JAK
- PMA / PMN Number
- K012009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) THE INVESTIGATION IS ON-GOING AND A FOLLOW-UP MDR WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED. (B)(4).
Description of Event or Problem · 1
PHILIPS RECEIVED A CUSTOMER COMPLAINT THAT ALLEGED WHEN A CURVED LINE IS DRAWN, THE IMAGE FLIPS. THERE ARE NO REPORTED INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BRILLIANCE EBW | EBW/JAK | JAK | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. | 728260 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |