FDA Adverse Event
Malfunction
Summary report: N
ALLURA XPER FD10 C
MDR report key: 2081160
·
Received April 14, 2011
Report
- Report Number
- 3003768277-2011-00333
- Event Type
- Malfunction
- Date Received
- April 14, 2011
- Report Date
- March 19, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- IZI
- PMA / PMN Number
- K031333
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE FIELD SERVICE ENGINEER DETERMINED THAT THE PROBLEM WAS CAUSED BY FLAT DETECTOR FAILURE DUE TO COOLANT LEAKAGE. THE COOLANT MOST LIKELY HAS CAUSED ELECTRICAL DAMAGE TO THE FLAT DETECTOR. HE REPLACED THE PARTS, THIS RESOLVED THE PROBLEM.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THERE IS NO IMAGE DURING FLUOROSCOPY AND CINE.
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 |