BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRSHIELDS ISOLETTE INFANT INCUBATOR

    MDR report key: 621512 · Received June 29, 2005

    Report

    Report Number
    621512
    Event Type
    Malfunction
    Date Received
    June 29, 2005
    Date of Event
    May 11, 2005
    Report Date
    June 29, 2005
    Manufacturer
    HILL-ROM MANUFACTURING INC
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A BURNING ODOR WAS NOTED IN THE NURSERY. THE ALARM ON AN ISOLETTE WAS SOUNDING. THE MOTOR ON THE ISOLETTE WAS NOTED TO BE BURNED. THE PT WAS IMMEDIATELY REMOVED AND WAS UNHARMED.FOLLOW UP REVEALS: IT WAS DETERMINED THAT THE SOLID STATE RELAY WAS BURNED AND THE MOTOR UNIT WAS NOTED TO GET TOO HOT. THE RELAY AND THE MOTOR WAS REPLACED AND NOTED TO BE IN WORKING ORDER AND THE ISOLETTE WAS RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRSHIELDS ISOLETTE INFANT INCUBATOR INFANT ISOLETTE FMZ HILL-ROM MANUFACTURING INC C100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA