FDA Adverse Event
Malfunction
Summary report: N
MULTIDIAGNOST ELEVA WITH FLAT
MDR report key: 2060865
·
Received March 14, 2011
Report
- Report Number
- 3003768277-2011-00274
- Event Type
- Malfunction
- Date Received
- March 14, 2011
- Report Date
- February 15, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- IZI
- PMA / PMN Number
- K050151
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT MAKING X-RAYS AND IMAGES IS NOT POSSIBLE. GREEN LAMP DOES GLOW ON DESK AND IN ROOM. DURING THE MAKING OF X-RAYS THERE IS NO RADIATION SIGN, BUT AN ORANGE LAMP. THE WARM RESTART DOES NOT SOLVE ANYTHING.
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 |