FDA Adverse Event
Malfunction
Summary report: N
MULTIDIAGNOST ELEVA WITH FLAT
MDR report key: 2081146
·
Received April 14, 2011
Report
- Report Number
- 3003768277-2011-00339
- Event Type
- Malfunction
- Date Received
- April 14, 2011
- Report Date
- March 18, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- IZI
- PMA / PMN Number
- K050151
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). WHEN INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT SYSTEM DID NOT GENERATE AN IMAGE WHILE X-RAY WHILE THE INDICATORS WERE ON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTIDIAGNOST ELEVA WITH FLAT | IZI, KPR | IZI | PHILIPS HEALTHCARE | 708034 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |