BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEUREVAC

    MDR report key: 14356 · Received June 27, 1994

    Report

    Report Number
    MW1002610
    Event Type
    Malfunction
    Date Received
    June 27, 1994
    Date of Event
    June 7, 1994
    Report Date
    June 8, 1994
    Manufacturer
    DEKNATEL DIV. PFIZER HOSPITAL PRODUCTS GRP., INC.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RPTR STATES DRY SUCTION NOT WORKING. SMALL BALL IS NOT RISING INTO VIEWING WINDOW. SUCTION HEAD OKAY. CONNECTIONS CORRECT. DRY DEVICE CHANGED TO WET DEVICE AND PROBLEM SOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEUREVAC SUCTION DEVICE KDQ DEKNATEL DIV. PFIZER HOSPITAL PRODUCTS GRP., INC. A-6000

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other