BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOLETTE

    MDR report key: 1021803 · Received March 20, 2008

    Report

    Report Number
    1021803
    Event Type
    Malfunction
    Date Received
    March 20, 2008
    Date of Event
    February 17, 2008
    Report Date
    March 20, 2008
    Manufacturer
    DRAEGER MEDICAL
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RN FOUND NEONATE TACHYCARDIC, TACHYPNEIC AND DECREASED SATURATIONS. BOTH BABY AND ISOLETTE WERE VERY WARM. WAS SET ON SERVO CONTROL BUT WAS FOUND ON AIR CONTROL, ATTEMPT TO CHANGE BUT ALARMED 'PROBE MALFUNCTION.' UNABLE TO CHANGE TO SERVO CONTROL. HAD TO TURN BED OFF TO DECREASE NEONATE'S TEMP FROM 101.9. AFTER TEMP DECREASED, ATTEMPT TO TURN BED BACK ON WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLETTE INCUBATOR, INFANT FMZ DRAEGER MEDICAL C2HS-1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 25 DA