BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FISHER AND PAYKEL HC MR290

    MDR report key: 4672500 · Received April 6, 2015

    Report

    Report Number
    MW5041998
    Event Type
    Injury
    Date Received
    April 6, 2015
    Date of Event
    March 17, 2015
    Report Date
    March 25, 2015
    Manufacturer
    F & P HEALTHCARE LTD
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HUMIDIFICATION CHAMBER FOUND TO HAVE A LEAK/CRACK WHILE IN USE ON A VENTED PATIENT. LOW TIDAL VOLUME NOTED PRIOR TO CRACK/LEAK FOUND. HUMIDIFIER/CIRCUIT PASSED THE INITIAL SAFETY SYSTEM TEST UP TO 90 CMH2O. HUMIDIFIER CHAMBER DEVELOPED CRACK ALONG SEAM WHILE ATTACHED TO THE PATIENT. UNSURE IF THE DAMAGE OCCURRED WHILE IN USE OR IF THE DEVICE WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226067 FISHER AND PAYKEL HC MR290 HUMIDIFICATION CHAMBER, MR290 BTT F & P HEALTHCARE LTD MR290 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention