FDA Adverse Event
Malfunction
Summary report: N
ALLURA XPER FD10 C
MDR report key: 2102834
·
Received April 12, 2011
Report
- Report Number
- 3003768277-2011-00371
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Report Date
- April 15, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- IZI
- PMA / PMN Number
- K031333
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A F/U REPORT WILL BE SENT TO THE FDA.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT ALL THE MONITORS OF THE ELECTROPHYSIOLOGY (EP) COCKPIT WENT BLANK. PHYSICIAN HAD NO VIDEO AND HAD TO WAIT FOR A SYSTEM REBOOT TO RESUME CASE, THERE WAS NO INJURY TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALLURA XPER FD10 C | IZI, MBQ | IZI | PHILIPS HEALTHCARE | 722001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |