BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDVAC

    MDR report key: 8784755 · Received July 12, 2019

    Report

    Report Number
    8784755
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    June 13, 2019
    Report Date
    June 14, 2019
    Manufacturer
    COVIDIEN LP
    Product Code
    FYD
    UDI-DI
    10884524001555
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE COVIDIEN SMOKE EVACUATOR, IT WAS NOT WORKING CONSISTENTLY. SMOKE EVAC JUST STOPS WORKING WITH NO EXPLANATION. STAFF IN ROOM BREATHING IN LARGE AMOUNTS OF PLUME FROM CASE. ALL CABLES, CONNECTIONS, FILTERS, AND THE BOVIE ITSELF CHECKED; NO APPARENT REASON FOR SMOKE EVAC TO BE WORKING ONLY INTERMITTENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578962 RAPIDVAC APPARATUS, EXHAUST, SURGICAL FYD COVIDIEN LP SE3690 10884524001555

    Patients

    Seq Age Sex Outcome Treatment
    1