BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1232538 · Received November 13, 2008

    Report

    Report Number
    9611451-2008-00670
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Report Date
    October 14, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. IN ADDITION, WE ARE IN THE PROCESS OF OBTAINING FURTHER INFORMATION IN RESPECT OF THE NATURE OF THE FAULT, EQUIPMENT SET-UP AND CIRCUMSTANCES SURROUNDING THE EVENT. WE ARE CURRENTLY AWAITING A RESPONSE. WE WILL PROVIDE A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND AN ANALYSIS IS AVAILABLE.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY REPORTED VIA A FISHER & PAYKEL HEALTHCARE CLINICAL PRODUCT SPECIALIST THAT AN MR290HFV AUTOFEED HUMIDIFICATION CHAMBER CRACKED WHILST IN USE ON A VENTILATOR. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED HUMIDIFICATION CHAMBER BTT FISHER & PAYKEL HEALTHCARE, LTD. MR290HFV 070920

    Patients

    Seq Age Sex Outcome Treatment
    1 VENTILATOR (MANUFACTURER UNKNOWN)