BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED ADULT/INFANT HUMIDIFICATION CHAMBER

    MDR report key: 2760109 · Received March 7, 2007

    Report

    Report Number
    9611451-2007-00068
    Event Type
    Malfunction
    Date Received
    March 7, 2007
    Report Date
    February 5, 2007
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MR290 HUMIDIFICATION CHAMBER IS BEING SENT BACK TO FISHER AND PAYKEL HEALTHCARE, (B)(4). METHOD: THERE IS NO INFO ON THIS TO DATE. RESULTS: NO EVALUATION HAS BEEN DONE PENDING THE RETURN OF THE DEVICE. CONCLUSIONS: INFO IS INSUFFICIENT AT THIS TIME TO MAKE A CONCLUSION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT, THE WATER ENTERING THE MR290 HUMIDIFICATION CHAMBER EXCEEDED THE LIMIT LINE OF THE MR290 HUMIDIFICATION CHAMBER, AND THAT THE WATER OVERFLOWED INTO THE BREATHING CIRCUIT AND VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED ADULT/INFANT HUMIDIFICATION CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290 060928

    Patients

    Seq Age Sex Outcome Treatment
    1 VENTILATOR - MANUFACTURER UNKNOWN| BREATHING CIRCUIT - MANUFACTURER UNKNOWN