BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD10

    MDR report key: 3874556 · Received April 22, 2014

    Report

    Report Number
    3003768277-2014-00039
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Report Date
    March 28, 2014
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K031333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    PHILIPS RECEIVED A COMPLAINT FROM A CUSTOMER THAT THERE IS A FOOTSWITCH BENT ISSUE. THIS ISSUE WAS CAUSED BY THE MALFUNCTION OF EXAMINATION ROOM'S FOOTSWITCH. THE PEDAL OF FLUOROSCOPY WAS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243738 ALLURA XPER FD10 IZI PHILIPS HEALTHCARE 722003

    Patients

    Seq Age Sex Outcome Treatment
    1