BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEWIRE

    MDR report key: 3151303 · Received May 6, 2013

    Report

    Report Number
    3151303
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 3, 2013
    Report Date
    May 6, 2013
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    AFTER NORMALIZING, CONNECTED PRIME WIRE MESSAGE READ (107) "PRESSURE WIRE HAS A SHORT CONDITION". EQUIPMENT REP CAME OUT AND CHECKED THE EQUIPMENT. IT WAS A SOFTWARE ISSUE WHICH WAS CORRECTED. THERE WAS NO HARM TO THE PATIENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196744 PRIMEWIRE WIRE, GUIDE, CATHETER DQX VOLCANO CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR
    2