BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREE STANDING INFANT WARMER

    MDR report key: 275193 · Received April 24, 2000

    Report

    Report Number
    2510954-2000-00007
    Event Type
    Malfunction
    Date Received
    April 24, 2000
    Date of Event
    March 14, 2000
    Report Date
    April 19, 2000
    Manufacturer
    HILL-ROM AIR-SHIELDS
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    24 WEEK GESTATIONAL AGE TWIN WAS OCCUPYING AN OHIO BRAND INFANT INCUBATOR WITH OPEN HOOD AND TEMPERATURE BEING REGULATED BY RADIANT WARMER. THE CALIBRATION SWITCH ON THE RADIANT WARMER ALLEGEDLY STUCK CAUSING A CONSTANT OUTPUT OF RADIANT HEAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREE STANDING INFANT WARMER INFANT RADIANT WARMER FMT HILL-ROM AIR-SHIELDS 7830 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention