BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z-FLO

    MDR report key: 2233075 · Received September 1, 2011

    Report

    Report Number
    2233075
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 31, 2011
    Report Date
    September 1, 2011
    Manufacturer
    SUNDANCE ENTERPRISES
    Product Code
    FMP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    UNIT NURSES EXPERIENCED THREE Z-FLO BRAND FLUIDIZED POSITIONER PACKS THAT BURST RESULTING IN RELEASE OF THE CONTENTS IN THE PACK. THE PACKS WERE BEING USED TO POSITION THE PATIENTS' HEADS OR UPPER BODY AREAS. UNITS WERE SENT TO BIOMEDICAL FOR EVALUATION.======================MANUFACTURER RESPONSE FOR FLUIDIZED POSITIONER, PATIENT POSITIONER, Z-FLO (PER SITE REPORTER)======================MANUFACTURER REPRESENTATIVE TO PICK UP 3 DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Z-FLO FLUIDIZED POSITIONER, PATIENT POSITIONER FMP SUNDANCE ENTERPRISES Z-FLO 1 7/041811/173, /164,/165

    Patients

    Seq Age Sex Outcome Treatment
    1 *