FDA Adverse Event
Malfunction
Summary report: N
MULTIDIAGNOST ELEVA
MDR report key: 2043396
·
Received February 25, 2011
Report
- Report Number
- 3003768277-2011-00217
- Event Type
- Malfunction
- Date Received
- February 25, 2011
- Report Date
- February 4, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- IZI
- PMA / PMN Number
- K050151
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS EVENT IS STILL UNDER INVESTIGATION. THE FOLLOW-UP REPORT WILL BE SENT BY (B)(4) 2011.
Description of Event or Problem · 1
THE SYSTEM IS DOWN, NO X-RAY. PATIENT IS ON TABLE UNDER ANESTHESIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTIDIAGNOST ELEVA | IZI, KPR | IZI | PHILIPS HEALTHCARE | 708037 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |