FDA Adverse Event
Malfunction
Summary report: N
ALLURA XPER FD20
MDR report key: 1912486
·
Received November 17, 2010
Report
- Report Number
- 3003768277-2010-00312
- Event Type
- Malfunction
- Date Received
- November 17, 2010
- Date of Event
- October 21, 2010
- Report Date
- October 21, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- IZI
- PMA / PMN Number
- K031333
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(CONCLUSIONS) - THE CUSTOMER REPORTED THAT THEY HEARD A LOUD POP AND SMOKE COMING FROM THE GENERATOR. A SERVICE ENGINEER WAS DISPATCHED TO THE SITE. THE ISSUE WAS SOLVED BY REPLACING A VELARA CONVERTOR AND ADAPTED TUBE. THE SYSTEM IS DESIGNED ACCORDING UL V=0. FLAME RETARDANT. NONE OF THE COMPONENTS HAVE EXCEPTIONAL OR INCREASED FAILURE RATES. FAILURE RATES AND RELIABILITY OF COMPONENTS ARE MONITORED. THEREFORE RISK TO PT REMAINS ACCEPTABLE. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THEY HEARD A LOUD POP AND SMOKE COMING FROM THE GENERATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALLURA XPER FD20 | IZI (SYSTEM, X-RAY ANGIOGRAPHIC) | IZI | PHILIPS MEDICAL SYSTEMS | 722006 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |