FDA Adverse Event
Malfunction
Summary report: N
ALLURA XPER FD10/10
MDR report key: 2243828
·
Received August 24, 2011
Report
- Report Number
- 3003768277-2011-00516
- Event Type
- Malfunction
- Date Received
- August 24, 2011
- Report Date
- August 1, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- IZI
- PMA / PMN Number
- K031333
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING THE EXAMINATION, THE SYSTEM MALFUNCTIONED W/O AN ERROR MESSAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALLURA XPER FD10/10 | IZI, MBQ | IZI | PHILIPS HEALTHCARE | 722005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |