BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL FILL INFANT HUMIDIFICATION CHAMBER

    MDR report key: 1200103 · Received October 15, 2008

    Report

    Report Number
    9611451-2008-00604
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Report Date
    September 15, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K913367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. NO RESULTS AND CONCLUSIONS ARE THEREFORE AVAILABLE AT PRESENT. A FOLLOW-UP REPORT WILL BE PREPARED AND FORWARDED AS SOON AS THE DEVICE HAS BEEN RETURNED AND INVESTIGATION RESULTS BECOME AVAILABLE. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR THIS LOT NUMBER.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED VIA A DISTRIBUTOR THAT AN AUTO FEED CHAMBER SPRANG A LEAK AT THE GLUE JOINT WHILE IN USE ON A VENTILATOR. THE EVENT WAS DESCRIBED AS FOLLOWS: "THE UNIT BEGAN SQUIRTING WATER OUT OF THE SEAM AND WAS CAUGHT IMMEDIATELY AND REPLACED." FISHER & PAYKEL HEALTHCARE ("FPH") MADE FURTHER INQUIRIES AND RECEIVED CLARIFICATION THAT THE EVENT INVOLVED AN MR225 MANUAL FILL INFANT/PEDIATRIC HUMIDIFICATION CHAMBER WHICH HAD SUFFERED SEAM FAILURE BETWEEN THE ALUMINIUM BASE AND THE CHAMBER. THE DEVICE WAS USED IN CONJUNCTION WITH THE 3100B HIGH FREQUENCY VENTILATOR AND HAD BEEN USED FOR 5 DAYS AT THE TIME OF THE EVENT. THE HOSPITAL CONFIRMED THAT WATER LEAKING FROM THE CHAMBER ALERTED HOSPITAL STAFF OF THE EVENT. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL FILL INFANT HUMIDIFICATION CHAMBER BTT FISHER & PAYKEL HEALTHCARE, LTD. MR225X 070524

    Patients

    Seq Age Sex Outcome Treatment
    1 BREATHING CIRCUIT| 900MR568 HEATER WIRE ADAPTER| MR730 RESPIRATORY HUMIDIFIER| 900MR559 TEMPERATURE PROBE| 3100B VENTILATOR