BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUA - EEZ

    MDR report key: 478456 · Received August 13, 2003

    Report

    Report Number
    478456
    Event Type
    Injury
    Date Received
    August 13, 2003
    Date of Event
    July 11, 2003
    Report Date
    August 13, 2003
    Manufacturer
    AQUA - EEZ
    Product Code
    ILJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED WITH TERM PREGNANCY IN ACTIVE LABOR. HYDROTHERAPY IN THE AQUA-EEZ DELUXE HYDROTHERAPY POOL WAS USED TO EASE LABOR. AT DELIVERY PT WAS FOUND TO HAVE A SHOULDER DYSTOCIA AND NEEDED TO BE REMOVED FROM THE POOL. THE POOL WOULD NOT DRAIN AND DELIVERY WAS DELAYED. THE BABY HAD METABOLIC ACIDOSIS AND SEIZURES AS WELL AS LOW APGARS. PROBLEM; AQUA-EEZ BIRTHING TUB DIDN'T DRAIN. CAUSE: THE RUBBER GASKET FOR THE FILTER ASSEMBLY WAS DISPLACED. WITHOUT THIS GASKET IN PLACE THE LID FOR THE FILTER ASSEMBLY WON'T SEAL AND NO SUCTION IS CREATED CAUSING THE TUB NOT TO DRAIN. ALSO ONE OF THE SCREW ASSEMBLIES THAT HOLDS THE FILTER LID IN PLACE WAS STRIPPED. THIS WAS CAUSED BY OVER TIGHTENING TRYING TO CREATE A SEAL WITHOUT THE GASKET IN PLACE. FIX; THE MAINTENANCE DEPT REPLACED THE SCREW AND GLUED THE GASKET IN PLACE. RESULT: THE AQUA-EEZ TUB IS OPERATIONAL AND SAFE TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUA - EEZ HYDROTHERAPY POOL ILJ AQUA - EEZ 3000M *

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| O