BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 1842084 · Received August 24, 2010

    Report

    Report Number
    9611451-2010-00509
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    February 1, 2010
    Report Date
    July 30, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RD900AEU NEOPUFF INFANT RESUSCITATOR IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A F/U REPORT ONCE WE RECEIVE THE COMPLAINT DEVICE AND HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A MEDICAL CENTER IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE'S CUSTOMER CARE SPECIALIST IN OUR US OFFICE THAT THEIR RD900AEU NEOPUFF INFANT RESUSCITATOR WAS "DEFECTIVE". 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 Unknown