BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BI-LEVEL CPAP SYSTEM

    MDR report key: 1007028 · Received March 3, 2008

    Report

    Report Number
    MW5005763
    Event Type
    Malfunction
    Date Received
    March 3, 2008
    Report Date
    March 3, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SINGLE USE FULL FACE BIPAP MASKS MADE BY FISHER AND PAYKEL LOT #070730 HAS A MASK LINING THAT DETACHES FROM THE MASK BASE RENDERING, IT IMPOSSIBLE TO MAINTAIN VOLUMES TO THE PT. NUMEROUS NEAR MISS PT EVENTS MADE IT NECESSARY TO PULL PRODUCT LINE OUT OF OUR HOSPITAL DISTRICT. IT WAS ALSO DECIDED BY THE PRODUCT SAFETY COMMITTEE AT VALLEY HEALTH SYSTEMS BASED TO REPORT PRODUCT DEFECT TO THE FDA. THE INEFFECTIVE SEAL CAUSED A GROSS LEAK THAT MADE IT IMPOSSIBLE TO SAFELY VENTILATE THE PT. DATES OF USE: 2007 - 2008. DIAGNOSIS OR REASON FOR USE: PTS WITH IMPENDING RESPIRATORY FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BI-LEVEL CPAP SYSTEM BIPAP MASK BZD FISHER & PAYKEL HEALTHCARE, INC. RT040S 070730

    Patients

    Seq Age Sex Outcome Treatment
    1 YR