BEUDAMED
    FDA Adverse Event Summary report: N

    FISHER & PAYKEL

    MDR report key: 343214 · Received July 19, 2001

    Report

    Report Number
    MW1022438
    Date Received
    July 19, 2001
    Date of Event
    July 15, 2001
    Report Date
    July 19, 2001
    Manufacturer
    FISHER & PAYKEL
    Product Code
    BTT
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    HEATER ALARMED; VISUAL INSPECTION REVEALED MELTED WIRE CONNECTION ON HEATED WIRE CABLE. THE HUMIDIFIER WAS ON A HAMILTON GALILEO VENTILATOR. THE WIRE CONNECTOR THAT MELTED WAS NOTED AT A POSITION AWAY FROM THE EXHALATION PORT OF THE VENTILATOR. THE HEATED HUMIDIFICATION SYSTEM WAS IN PLACE 3 DAYS. THE CONNECTOR WIRE IS (0060-23) MANUFACTURED BY ALLEGIANCE HEALTHCARE CORP., MCGAW PARK, ILLINOIS 60085.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32735 FISHER & PAYKEL HEATED HUMIDIFIER BTT FISHER & PAYKEL MR-730 CABLE F7547671

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR CORP., MCGAW PARK, IL 60085.| 1) CONNECTOR WIRE (0060-23), ALLEGIANCE HEALTHCARE