BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE GUIDE WIRE

    MDR report key: 3646999 · Received February 21, 2014

    Report

    Report Number
    3646999
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    November 8, 2013
    Report Date
    February 21, 2014
    Manufacturer
    VOLCANO CORP
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    PRIMEWIRE WAS PROPERLY PREPPED. WHEN PLUGGED IN, SMART BOX GAVE AN "UNSTABLE" READING. BOX WAS EXCHANGED. NEW BOX READ SAME MESSAGE. NEW WIRE WAS OPENED AND WORKED FINE. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110128 PRESSURE GUIDE WIRE WIRE, GUIDE, CATHETER DQX VOLCANO CORP 9185 011050002415063

    Patients

    Seq Age Sex Outcome Treatment
    1 *