FDA Adverse Event
Malfunction
Summary report: N
ALLURA XPER FD10/10
MDR report key: 2036733
·
Received February 18, 2011
Report
- Report Number
- 3003768277-2011-00180
- Event Type
- Malfunction
- Date Received
- February 18, 2011
- Report Date
- January 24, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- IZI
- PMA / PMN Number
- K041949
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS EVENT IS STILL UNDER INVESTIGATION. THE F/U REPORT WILL BE SENT BY 04/22/2011.
Description of Event or Problem · 1
THE CUSTOMER STATES THAT: "THE FLUOROSCOPY FAILED, THE EXPOSURE FAILED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALLURA XPER FD10/10 | IZI, MBQ | IZI | PHILIPS HEALTHCARE | 722011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |