BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACISER

    MDR report key: 36920 · Received September 6, 1996

    Report

    Report Number
    MW1009874
    Event Type
    Malfunction
    Date Received
    September 6, 1996
    Date of Event
    August 14, 1996
    Report Date
    August 20, 1996
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    2/96 - FACILITY NOTIFIED VERBALLY BY MFR OF POSSIBILITY OF CORROSION OF HOSE CONNECTIONS AND RESULTING LEAK OF HYDRAULIC FLUID. 3/23/96 CO REP AT FACILITY TO REPAIR UNIT AND TAKE CARE OF HOSE CONNECTIONS. REP DECIDED THAT HOSE CONNECTIONS WERE NOT A PROBLEM AND DID NOT REPLACE THEM. 8/14/96 LEAK OF ALL THE HYDRAULIC FLUID (3 GALLONS) INTO POOL. MSDS STATES THAT FLUID CAN CAUSE SKIN OR EYE PROBLEMS. NO KNOWN PT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUACISER HYDRO-MASSAGE BATH ILJ FERNO-WASHINGTON, INC. 976 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *