BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9611451-2008-00030

    MDR report key: 991864 · Received February 7, 2008

    Report

    Report Number
    9611451-2008-00030
    Event Type
    Malfunction
    Date Received
    February 7, 2008
    Date of Event
    January 3, 2008
    Report Date
    January 3, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K913367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS PREPARED BY REP. THE COMPLAINT DEVICE IS NOT AVAILABLE FOR EVAL. A REQUEST FOR FURTHER INFO HAS BEEN SENT TO THE HOSP. RESULTS: INVESTIGATION STILL UNDERWAY, NO RESULTS TO DATE. OUR RECORDS INDICATE THAT ONE OTHER COMPLAINT (TOTAL TWO COMPLAINTS) OF THIS NATURE HAS BEEN REC'D FOR THE GIVEN LOT NUMBER. CONCLUSIONS: NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    A HOSPITAL IN THE US REPORTED TO OUR DISTRIBUTOR THAT A MR225 INFANT HUMIDIFICATION CHAMBER WAS 'LEAKING WATER WHERE THE ALUMINIUM SEAL MEETS THE PLASTIC DOME'. THEY WERE USING THE CHAMBER WITH AN AIRLIFE INFANT CPAP DRIVER. NO PT CONSEQUENCE WAS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BTT FISHER & PAYKEL HEALTHCARE, LTD. MR225 070504

    Patients

    Seq Age Sex Outcome Treatment
    1