BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL FILL INFANT HUMIDIFICATION CHAMBER

    MDR report key: 1203451 · Received October 17, 2008

    Report

    Report Number
    9611451-2008-00616
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 13, 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
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). 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.

    Description of Event or Problem · 1

    A HOSPITAL IN (B) (6) REPORTED VIA A DISTRIBUTOR THAT THE MR225 MANUAL FILL INFANT/PEDIATRIC HUMIDIFICATION CHAMBER BURST, WHEN USED IN CONJUNCTION WITH A HIGH FLOW NASAL CANNULA SYSTEM AT A FLOW RATE OF 4 LITRES/MIN. TWO CHAMBERS WERE AFFECTED. UPON REQUEST FOR ADDITIONAL INFO VIA OUR DISTRIBUTOR, IT WAS FURTHER REPORTED THAT THE SET-UP CONSISTED OF THE RT132 INFANT CONTINUOUS FLOW BREATHING CIRCUIT, MR850 HUMIDIFICATION CHAMBER AND ALLEGIANCE 2C7103 CHAMBER WATER FEEDSET, WITHOUT ANY PRESSURE RELIEF DEVICES UTILIZED. NO PATIENT 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. MR225

    Patients

    Seq Age Sex Outcome Treatment
    1 ALLEGIANCE 2C7103 CHAMBER WATER FEEDSET| CONTINUOUS FLOW BREATHING CIRCUIT| MR850 HUMIDIFICATION CHAMBER| FISHER & PAYKEL HEALTHCARE RT132 INFANT