BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD20

    MDR report key: 1942747 · Received December 3, 2010

    Report

    Report Number
    3003768277-2010-00348
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 12, 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 FIELD SERVICE ENGINEER FOUND PROBLEM WITH THE TABLE BASE CONNECTION BOARD. THERE WERE FLUIDS CAUSING CORROSION ESPECIALLY ON THE FOOTSWITCH CONNECTOR. AFTER THE REPLACEMENT OF THE BOARD ((B)(4) BOX TBCB BOARD AD7) THE PROBLEM WAS SOLVED. BASED ON TRENDING ANALYSIS, WE CONCLUDE THAT THERE IS NO EXCEPTIONAL REPLACEMENT RATE FOR THIS COMPONENT. THERE IS NO NEED FOR MANDATORY FIELD ACTION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WAS PERFORMING CINE WHEN THE FLUORO ON THE FOOTSWITCH WAS DEPRESSED.

    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