BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C100QT INFANT INCUBATOR

    MDR report key: 200750 · Received December 7, 1998

    Report

    Report Number
    2510954-1998-00008
    Event Type
    Malfunction
    Date Received
    December 7, 1998
    Date of Event
    November 9, 1998
    Report Date
    November 10, 1998
    Manufacturer
    HILL-ROM AIR-SHIELDS
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A MONITOR WAS ALARMING AND THE INFANT WAS FOUND ON THE FLOOR AWAKE AND ALERT. IT WAS REPORTED THAT A REAR ACCESS PORT DOOR WAS FOUND OPEN. THE HOSPITAL BIOMEDICAL GROUP REPORTED DAMAGED COMPONENTS WERE FOUND ON THE PORT DOOR LATCH ASSEMBLY, WHICH WERE REPLACED PRIOR TO THE VISIT OF HILL-ROM AIR-SHIELDS SERVICE ENGINEER ON NOVEMBER 10, 1998. NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C100QT INFANT INCUBATOR INFANT INCUBATOR FMZ HILL-ROM AIR-SHIELDS C100QT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA