BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FISHER PAYKEL

    MDR report key: 1060579 · Received June 9, 2008

    Report

    Report Number
    MW5007269
    Event Type
    Injury
    Date Received
    June 9, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 27, 2008
    Manufacturer
    FISHER PAYKEL HEALTHCARE INC.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FISHER/PAYKEL AUTO FEED WATER RESERVOIR MALFUNCTIONED. THE FLOAT DID NOT STOP THE WATER FROM FILLING THE PT CIRCUIT AS ANTICIPATED. IDENTIFIED AND D/C. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FISHER PAYKEL WATER RESERVOIR BTT FISHER PAYKEL HEALTHCARE INC. MR 290 0803030504

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention