FDA Adverse Event
Malfunction
Summary report: N
ALLURA XPER FD10
MDR report key: 2211943
·
Received August 10, 2011
Report
- Report Number
- 3003768277-2011-00494
- Event Type
- Malfunction
- Date Received
- August 10, 2011
- Report Date
- July 14, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- IZI
- PMA / PMN Number
- K031333
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE FIELD SVC ENGINEER (FSE) TROUBLESHOT THE SYS AND FOUND A PROBLEM WITH CENTRAL PROCESSING UNIT BOARD (SYS INTERFACE BOARD). HE REPLACED THE BOARD, AND INSTALLED (B)(4), THIS SOLVED THE PROBLEM.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT CONSOLE IS FROZEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALLURA XPER FD10 | IZI, MBQ | IZI | PHILIPS HEALTHCARE | 722003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |