BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD20 OR TABLE

    MDR report key: 4355816 · Received December 17, 2014

    Report

    Report Number
    3003768277-2014-00132
    Event Type
    Malfunction
    Date Received
    December 17, 2014
    Report Date
    November 20, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    IZI
    PMA / PMN Number
    K102005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 THE FOOTSWITCH WAS INTERMITTENTLY NOT WORKING. THE SWITCH WAS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830046 ALLURA XPER FD20 OR TABLE ANGIOGRAPHIC X-RAY SYSTEM IZI PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 722023

    Patients

    Seq Age Sex Outcome Treatment
    1