FDA Adverse Event
Malfunction
Summary report: N
INTEGRIS ALLURA 9 (BIPLANE)
MDR report key: 2193476
·
Received July 13, 2011
Report
- Report Number
- 3003768277-2011-00446
- Event Type
- Malfunction
- Date Received
- July 13, 2011
- Report Date
- June 17, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- IZI
- PMA / PMN Number
- K002016
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). WHEN INVESTIGATION IS COMPLETED, A F/U REPORT WILL BE SENT TO THE FDA.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM RESTARTS EVERY 15 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTEGRIS ALLURA 9 (BIPLANE) | IZI | PHILIPS HEALTHCARE | 722021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |