BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 1230841 · Received October 28, 2008

    Report

    Report Number
    9611451-2008-00629
    Event Type
    Malfunction
    Date Received
    October 28, 2008
    Report Date
    October 1, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WILL BE CONDUCTED ONCE WE RECEIVE THE COMPLAINT DEVICE. A FOLLOW UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN COLOMBIA REPORTED THAT THEY RECEIVED A NEOPUFF INFANT RESUSCITATOR, BUT THE ACRYLIC FACE OF THE MANOMETER WAS BROKEN. 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. RD900ASU

    Patients

    Seq Age Sex Outcome Treatment
    1