BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL 850 RESPIRATORY HUMIDIFICATION SYSTEM

    MDR report key: 371747 · Received December 20, 2001

    Report

    Report Number
    MW4003173
    Event Type
    Malfunction
    Date Received
    December 20, 2001
    Date of Event
    November 2, 2001
    Report Date
    December 18, 2001
    Manufacturer
    FISHER & PAYKEL HEALTH CARE INC.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON NORMAL EXTENDED SELF TEST (EST) OF THE PURITAN BENNETT 7200 VENTILATOR AN ERROR CODE WAS REALIZED REPEATIVELY. BIO-MED WAS SUMMONED AND MADE THE REPAIR OF THE VENT WHICH WAS A Q-3 SENSOR AND BOARD. AGAIN A DIFFERENT VENTILATOR HAS THE SAME PROBLEM. BIO-MED WAS CALLED AGAIN. THEY SAID WATER WAS GETTING INTO THE MACHINE. THE ONLY DIFFERENCE IS THAT HOSP HAS A NEW HUMIDIFICATION SYSTEM ON THE VENTILATORS. THEY CALLED PURITAN-BENNETT AND THE TECH SUPPORT PERSON STATED THAT THE 7200 WAS NOT DESIGNED TO ACCOMMODATE A HEATED EXPIRATORY LIMB ON THERE CIRCUITS. THE EXPIRED AIR IS HEATED AND THE FIRST THING COLD IT ENCOUNTERS IS THE Q-3 SENSOR, WHERE THE HEATED VAPOR RAINS OUT (DEW POINT) AND GETS THE INSIDE OF THE MACHINE WET. THE CIRCUIT ALSO INVOLVED AS PART OF THAT SYSTEM IS THE AIRLIFE CIRCUIT TM, CAT# RT110, MFG BY FISHER & PAYKEL AND DISTRIBUTED BY ALLEGIANCE. NO PTS WERE AFFECTED OR KNOWN TO BE AFFECTED. NO ERROR CODES OR MALFUNCTIONS WERE NOTED DURING PT USE. THE MACHINES WERE TAGGED AND SECURED UNTIL A SOLUTION WAS DEVELOPED WITH THE ASSISTANCE AND SUGGESTIONS FROM BOTH PB TECHNICAL SUPPORT AND FISHER & PAYKEL CLINICAL SPECIALIST. NO PROBLEMS HAVE BEEN NOTED SINCE A NON-HEATED EXPIRATORY LIMB HAS BEEN IMPLIMENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58545 FISHER & PAYKEL 850 RESPIRATORY HUMIDIFICATION SYSTEM HUMIDIFIER BTT FISHER & PAYKEL HEALTH CARE INC. 850 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA PURITAN BENNETT 7200 VENTILATOR, 2001| AIRLIFE CIRCUIT TM CAT# RT110, 2001