BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 969430 · Received December 21, 2007

    Report

    Report Number
    9611451-2007-00483
    Event Type
    Malfunction
    Date Received
    December 21, 2007
    Report Date
    November 21, 2007
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTM
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS PREPARED BY R. PETRY. WE ARE AWAITING THE RETURN OF THE COMPLAINT DEVICE FROM THE US TO NEW ZEALAND TO BEGIN THE INVESTIGATION.

    Description of Event or Problem · 1

    THE MANOMETER HAS STOPPED WORKING, NEEDS REPAIR. NO PT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOPUFF INFANT RESUSCITATOR GAS POWERED T PIECE INFANT RESUSCITATOR BTM FISHER & PAYKEL HEALTHCARE LTD RD900 040803

    Patients

    Seq Age Sex Outcome Treatment
    1 YR