BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSITATOR

    MDR report key: 1170681 · Received September 16, 2008

    Report

    Report Number
    9611451-2008-00530
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Report Date
    August 18, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A HOSPITAL REPORTED THAT THE GAS INLET OF NEOPUFF INFANT RESUSCITATOR HAD CRACKED THUS, IT WAS NOT HOLDING OR FITTING TIGHTLY. NO PT CONSEQUENCE WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1