BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRSHIELDS

    MDR report key: 438707 · Received January 20, 2003

    Report

    Report Number
    MW1027320
    Event Type
    Malfunction
    Date Received
    January 20, 2003
    Date of Event
    January 19, 2003
    Report Date
    January 20, 2003
    Manufacturer
    HILL-ROM AIR SHIELDS INC
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PT FELL OUT OF THE ACCESS DOOR OF AN INCUBATOR. BIO-MED EVALUATED THE DEVICE AND FOUND THE FOLLOWING: THREE OF THE LATCHES WERE FOUND TO REQUIRE THE OPERATOR TO PUSH ON THE DOOR TO FULLY ENGAGE THE LATCH, A SIMPLE FLIP OF THE DOOR WOULD ONLY HALFWAY ENGAGE THE DOOR LATCH. THESE WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRSHIELDS INFANT INCUBATOR FMZ HILL-ROM AIR SHIELDS INC C100/200-2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *