BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIHEART NEBULIZER

    MDR report key: 275648 · Received April 17, 2000

    Report

    Report Number
    MW1018763
    Event Type
    Malfunction
    Date Received
    April 17, 2000
    Report Date
    April 14, 2000
    Manufacturer
    WESTMED, INC.
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EMERGENCY DEPT PURCHASED THE "UNIHEART NEBULIZER" TO BE ABLE TO GIVE MULTIPLE, BACK TO BACK NEBULIZED MEDICATION TREATMENTS TO PEDIATRIC PTS. IT WAS NOTED THAT A YOUNG PT REMOVED A TINY PLASTIC PIECE THAT IS DETACHABLE FROM THE UNIT. HOSP'S CONCERN IS THAT A PEDIATRIC PT MAY CHOKE ON THIS LITTLE PIECE OF PLASTIC. ALL DEVICES WERE REMOVED FROM SVC AND SENT BACK TO MFR. HOSP NOTIFIED THE DISTRIBUTOR OF THE PROBLEM. NO ONE WAS HURT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIHEART NEBULIZER UNIVERSAL LOW FLOW-EXTENDED TREATMENT NEBULIZER CAF WESTMED, INC. 100941 06017

    Patients

    Seq Age Sex Outcome Treatment
    1 *