BEUDAMED
    FDA Adverse Event Other Summary report: N

    HILL-ROM AIRSHIELDS ISOLETTE INFANT INCUBATOR

    MDR report key: 550756 · Received August 31, 2004

    Report

    Report Number
    550756
    Event Type
    Other
    Date Received
    August 31, 2004
    Date of Event
    August 26, 2004
    Report Date
    August 31, 2004
    Manufacturer
    HILL-ROM MANUFACTURING, INC.
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A PATIENT ROLLED AGAINST AN UNSECURED PORT DOOR ON AN AIR SHIELDS ISOLETTE (MODEL C100) AND FELL OUT OF THE ISOLETTE. AS THE PATIENT ROLLED OUT OF THE PORT DOOR, THE PULSE OXIMETER'S SENSOR ATTACHED TO THE PATIENT'S FOOT PREVENTED, THE PATIENT FROM REACHING THE FLOOR. THE RESULTS OF AN IMMEDIATE EXAMINATION OF THE PATIENT CONCLUDED THAT THERE WERE NO INJURIES AS A RESULT OF THE FALL. THE ISOLETTE WAS REMOVED FROM SERVICE. BIOMEDICAL ENGINEERING EXAMINED THE ISOLETTE AND IDENTIFIED THAT THE LATCH ON THE OLDER STYLE C100 PORT DOORS HAVE TO BE PUSHED UNTIL A CLICK IS HEARD WHICH INDICATES THAT THE DOOR IS SECURELY CLOSED. THE DOOR CAN BE HELD IN PLACE WITHOUT BEING FULLY SECURED WHICH WAS THE CAUSE OF THE FALL. BIOMEDICAL ENGINEERING IDENTIFIED THREE OTHER C100 ISOLETTES WITH THIS TYPE OF LATCH AND REMOVED THEM FROM SERVICE. BIOMEDICAL ENGINEERING HAS REPLACED THE LATCHES ON TWO OF THE C100 ISOLETTES WITH NEWER STYLE LATCHES. THE NEWER STYLE LATCHES REQUIRE LESS EFFORT TO CLOSE AND SECURE THE DOOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *