BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUA - EEZ

    MDR report key: 451236 · Received March 7, 2003

    Report

    Report Number
    2434117-2003-00002
    Event Type
    Malfunction
    Date Received
    March 7, 2003
    Date of Event
    January 25, 2003
    Report Date
    February 4, 2003
    Manufacturer
    AQUA - EEZ, INC.
    Product Code
    ILJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DELIVERY INITIATED IN BIRTHING TUB PARENT MOVED TO BED TO COMPLETE DELIVERY. TUB FAILED TO DRAIN ACCORDING TO GUIDELINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUA - EEZ BIRTHING TUB ILJ AQUA - EEZ, INC. 3020 *

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Hospitalization