FDA Adverse Event
Malfunction
Summary report: N
ALLURA XPER FD20
MDR report key: 1942782
·
Received December 1, 2010
Report
- Report Number
- 3003768277-2010-00344
- Event Type
- Malfunction
- Date Received
- December 1, 2010
- Date of Event
- October 25, 2010
- Report Date
- October 25, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- IZI
- PMA / PMN Number
- K031333
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSIONS: THE INVESTIGATION FOUND THE PROBLEM WAS RESOLVED BY REPLACING A DEFECTIVE CONTROL UNIT. THE REPLACEMENT OF THIS HARDWARE WHICH MIGHT HAVE CONTRIBUTED OR CAUSED THE REPORTED PROBLEM FIXED THE SYSTEM. HOWEVER, THE ROOT CAUSE IS STILL UNK. THE FAILURE RATES AND RELIABILITY OF COMPONENTS ARE MONITORED FOR POSSIBLE ACTIONS. THIS COMPONENT HAS NO EXCEPTIONAL OR INCREASED FAILURE RATE. THERE IS NO NEED FOR MANDATORY FIELD ACTION. (B)(4).
Description of Event or Problem · 1
THIS X-RAY SYSTEM WAS REPORTED TO HAVE SHUT OFF DURING A CASE WITH A PT ON THE TABLE. THE SYSTEM WOULD NOT TURN BACK ON.
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 |