FDA Adverse Event
Death
Summary report: N
ALLURA XPER FD10 C
MDR report key: 2040786
·
Received March 31, 2011
Report
- Report Number
- 3003768277-2011-00286
- Event Type
- Death
- Date Received
- March 31, 2011
- Date of Event
- March 7, 2011
- Report Date
- March 7, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- IZI
- PMA / PMN Number
- K031333
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- 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
A PHILIPS HEALTHCARE PROJECT MANAGER (B)(6) VISITED CUSTOMER (B)(6). THIS WAS A STANDARD MEDICAL PROCEDURE, DURING THIS OPERATION PT DIED. THE DOCTORS TRIED TO RESUSCITATE HIM BUT UNFORTUNATELY TO NO AVAIL. DOCTOR (B)(6) ALSO CONFIRMED THAT EVERYTHING WAS DONE WITH RESPECT TO STANDARD MEDICAL PROCEDURES. HE ALSO CONFIRMED THAT PT'S DEATH WAS NOT CONNECTED WITH CARDIO ANGIOGRAPHY SYSTEM PERFORMANCE.
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 | 80 YR | Death |