BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD10

    MDR report key: 3871621 · Received April 16, 2014

    Report

    Report Number
    3003768277-2014-00033
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Report Date
    March 19, 2001
    Manufacturer
    PHILIPS HEALTHCARE C
    Product Code
    IZI
    PMA / PMN Number
    K031333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIELD SERVICE ENGINEER (CSE) TROUBLESHOT THE SYSTEM AND FOUND A PROBLEM WITH THE FOOTSWITCH. HE REPLACED THE FOOTSWITCH. THE EXPOSURE PEDAL OF THE FOOTSWITCH, WHEN USED ON THE PEDESTAL OR WHEN THE FOOTSWITCH IS USED ON AN ANTI-FATIGUE MAT, CAN BE BENT DOWNWARDS AND THE EXPOSURE WOULD NOT BE POSSIBLE BECAUSE PEDAL WILL TOUCH THE FLOOR AND THE MICRO-SWITCH WOULD NOT ACTIVATE. THE FOOTSWITCH WAS DESIGNED TO BE USED ON A SOLID SURFACE. TO BE ABLE TO USE THE FOOTSWITCH WITH AN ANTI-FATIGUE MAT A DESIGN CHANGE IN THE FOOTSWITCH NEEDS TO TAKE PLACE. PHILIPS IS ALSO WORKING ON THE REDESIGN OF THE PEDAL PLATE IN THE PEDESTAL TO PREVENT BENDING.

    Description of Event or Problem · 1

    PHILIPS RECEIVED A COMPLAINT FROM A CUSTOMER THAT THE CUSTOMER REPEATEDLY HAD PROBLEMS CONCERNING A BENT FOOT SWITCH. DUE TO THE BENT FOOTSWITCH, IT WAS NOT POSSIBLE TO START FLUOROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233442 ALLURA XPER FD10 IZI PHILIPS HEALTHCARE C 722003

    Patients

    Seq Age Sex Outcome Treatment
    1