FDA Adverse Event
Malfunction
Summary report: N
EASYDIAGNOST ELEVA
MDR report key: 1930387
·
Received November 18, 2010
Report
- Report Number
- 3003768251-2010-00205
- Event Type
- Malfunction
- Date Received
- November 18, 2010
- Date of Event
- February 6, 2009
- Report Date
- February 11, 2009
- Manufacturer
- PHILIPS MEDICAL SYSTEMS DMC GMBH
- Product Code
- IXR
- PMA / PMN Number
- K970640
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE CUSTOMER ALLEGED THAT A PT'S NAME IN A STUDY CHANGED AT THE VIEWFORUM. THERE WAS NO MIXUP OF PT IMAGE / DATA IN THE PACS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EASYDIAGNOST ELEVA | IXR | PHILIPS MEDICAL SYSTEMS DMC GMBH | 706031 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |