BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 1230987 · Received October 28, 2008

    Report

    Report Number
    9611451-2008-00628
    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 ANOTHER COUNTRY REPORTED THAT THEY RECEIVED AN RD900ASU 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