BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 383691 · Received March 13, 2002

    Report

    Report Number
    9611451-2002-00001
    Event Type
    Other
    Date Received
    March 13, 2002
    Date of Event
    February 28, 2002
    Report Date
    March 13, 2002
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED FROM DISTRIBUTOR: "THE ISOTHERMAL INFANT CIRCUIT MELTED DOWN ON THE EXPIRATORY LIMB WHICH WAS LAYING ON THE PT'S LEG CAUSING A BURN ON THE PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * HEATED RESPIRATORY HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE LTD MR730 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other