FDA Adverse Event
Malfunction
Summary report: N
ALLURA XPER FD10
MDR report key: 1872860
·
Received September 29, 2010
Report
- Report Number
- 3003768277-2010-00218
- Event Type
- Malfunction
- Date Received
- September 29, 2010
- Date of Event
- July 19, 2010
- Report Date
- July 19, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- IZI
- PMA / PMN Number
- K031333
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSIONS - CUSTOMER REPORTED TRIPPING OF FUSE DURING NORMAL OPERATION. REPLACEMENT OF THE FUSE DOES NOT SHOW AN EXCEPTIONAL FAILURE RATE AND AN ACCEPTABLE LIFE SPAN FOR THIS TYPE OF COMPONENT. THEREFORE, THE RISK TO PATIENT HEALTH DUE TO THIS TYPE OF FAILURE IS NOT INCREASED AND REMAINS ACCEPTABLE. THERE IS NO NEED FOR A MANDATORY FIELD ACTION.
Description of Event or Problem · 1
CUSTOMER REPORTED TRIPPING OF FUSE DURING NORMAL OPERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALLURA XPER FD10 | IZI (SYSTEM, X-RAY ANGIOGRAPHIC) | IZI | PHILIPS MEDICAL SYSTEMS | 722001 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |