FDA Adverse Event
Death
Summary report: N
ALLURA XPER FD10
MDR report key: 2894051
·
Received December 27, 2012
Report
- Report Number
- 3003768277-2012-00089
- Event Type
- Death
- Date Received
- December 27, 2012
- Date of Event
- December 18, 2012
- Report Date
- December 21, 2012
- Manufacturer
- PHILIPS HEALTHCARE - BEST NETHERLANDS
- Product Code
- IZI
- PMA / PMN Number
- K031333
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVAL METHOD, RESULT, CONCLUSION: INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING A FLUOROSCOPY PROCEDURE, SYSTEM WAS FAILED. THE PT WAS MOVED TO ANOTHER ROOM AND THERE THE PT DIED. IT IS NOT CLEAR WHETHER THE SYSTEM CONTRIBUTED TO THE DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALLURA XPER FD10 | IZI, MQB | IZI | PHILIPS HEALTHCARE - BEST NETHERLANDS | 722003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |