FDA Adverse Event
Malfunction
Summary report: N
ALLURA XPER FD10 C
MDR report key: 2093914
·
Received April 19, 2011
Report
- Report Number
- 3003768277-2011-00341
- Event Type
- Malfunction
- Date Received
- April 19, 2011
- Report Date
- March 21, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- IZI
- PMA / PMN Number
- K031333
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). WHEN INVESTIGATION IS COMPLETED A F/U REPORT WILL BE SENT TO THE FDA.
Description of Event or Problem · 1
THE CUSTOMER STATES THAT "AN ERROR MESSAGE WAS DISPLAYED ON SCREEN AND UNABLE TO SWITCH VIDEO, CALL SERVICE." THE VIDEO IS STILL DISPLAYED BUT THE TOUCH SCREEN CONTROLS AND COCKPIT CONTROL ARE UNRESPONSIVE. NO INJURY OCCURRED.
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 | 19 YR |