BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAUNA LOA LAVABED 2

    MDR report key: 167505 · Received May 6, 1998

    Report

    Report Number
    MW1013772
    Event Type
    Injury
    Date Received
    May 6, 1998
    Date of Event
    April 23, 1998
    Report Date
    May 4, 1998
    Manufacturer
    OWENS-BRIGAM MEDICAL CO.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN-LINE HUMIDIFIER CARTRIDGE HAD A PLASTIC SEALED WATER FEED CHAMBER WHICH PREVENTED PRIMING OF CARTRIDGE. 19 GAUGE STERILE NEEDLE USED TO PIERCE PLASTIC MEMBRANE & WATER INFUSED INTO RESERVOIR. VENTILATOR ASSISTED RATE TESTED & DIMINISHED FLOW NOTED WHEN CIRCIUIT CONNECTED TO PT TO PROVIDE VENTILATION AT A RATE OF 30 BREATHS PER MINUTE. DISCONNECTED CIRCUIT FROM PT AND BYPASSED HUMIDIFICATION CARTRIDGE FOR 45 MIN DURING PT TRANSFER TO LEVEL III INTENSIVE CARE UNIT BY AMBULANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAUNA LOA LAVABED 2 IN-LINE VENTILATOR HUMIDIFICATION CARTRIDGE BTT OWENS-BRIGAM MEDICAL CO. LAVABED 2 21724

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Hospitalization 28 WK GESTATION PREMATURE IMPLANT WITH| RESPIRATORY DISTRESS.