FDA Adverse Event
Malfunction
Summary report: N
ALLURA XPER FD10
MDR report key: 2012219
·
Received February 1, 2011
Report
- Report Number
- 3003768277-2011-00063
- Event Type
- Malfunction
- Date Received
- February 1, 2011
- Report Date
- January 4, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- IZI
- PMA / PMN Number
- K031333
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA BY 04/02/2011.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT SOMETIMES THE IMAGE DISAPPEARS, AS IF THE MONITOR WERE TURNING OFF.
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 |