BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARE PLUS INCUBATOR

    MDR report key: 701740 · Received October 13, 2005

    Report

    Report Number
    1121732-2005-00017
    Event Type
    Malfunction
    Date Received
    October 13, 2005
    Date of Event
    September 10, 2005
    Report Date
    October 11, 2005
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    AN INFANT FELL THROUGH THE PORT HOLE OF THE CARE-PLUS INCUBATOR AND SUSTAINED BRUISES. OHMEDA MEDICAL'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARE PLUS INCUBATOR INFANT THERMOREGULATION FMZ OHMEDA MEDICAL CARE PLUS INCUBATOR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 DAY