BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2536278 · Received March 29, 2012

    Report

    Report Number
    2536278
    Event Type
    Malfunction
    Date Received
    March 29, 2012
    Date of Event
    February 16, 2012
    Report Date
    March 29, 2012
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    THE ISOLETTE MALFUNCTIONED AND THE BABY GOT OVERHEATED. THE DEVICE WAS REMOVED FROM THE POD AND WORK ORDER PLACED. BABY MONITORED AND THE TEMPERATURE CAME BACK TO NORMAL. THERE WAS NO HARM TO THE CHILD. BIOMED TESTED DEVICE, AND COULD NOT DUPLICATE PROBLEM. UNIT WAS RUN OVER NIGHT WITH NO ALARMS OR MALFUNCTIONS AND ALL REQUIRED TESTS PASSED WITHIN NORMAL OPERATING PARAMETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * INCUBATOR, NEONATAL FMZ OHMEDA MEDICAL 6600-0084-800 *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 *