BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 1083871 · Received July 28, 2008

    Report

    Report Number
    9611451-2008-00273
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Report Date
    July 1, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE COMPLAINT DEVICE IS CURRENTLY BEING INVESTIGATED. A F/U REPORT WILL BE PROVIDED ONCE WE RECEIVE THE INVESTIGATION REPORT.

    Description of Event or Problem · 1

    A MEDICAL CENTER IN (B) (6) REPORTED THAT THE INSPIRATORY PRESSURE OF RD900AEU NEOPUFF INFANT RESUSCITATOR WAS UNSTABLE BETWEEN 40 AND 80 CM H2O. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOPUFF INFANT RESUSCITATOR BTL FISHER & PAYKEL HEALTHCARE, LTD. RD900AEU

    Patients

    Seq Age Sex Outcome Treatment
    1