BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 1668630 · Received April 21, 2010

    Report

    Report Number
    9611451-2010-00239
    Event Type
    Malfunction
    Date Received
    April 21, 2010
    Report Date
    March 31, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT NEOPUFF WAS RETURNED TO FISHER & PAYKEL HEALTHCARE'S REGIONAL OFFICE AND SERVICE CENTER IN (B)(4) FOR EVALUATION AND SERVICE. THE SERVICE CENTER PERFORMANCE TESTED THE DEVICE. RESULTS: THE COMPLAINT NEOPUFF FUNCTIONED PROPERLY DURING TESTING AND PASSED ALL FUNCTIONAL TESTS. THE REPORTED FAULT WAS NOT REPLICATED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 090505. CONCLUSION: NO FAULT WAS FOUND WITH THE COMPLAINT DEVICE AS IT OPERATED PROPERLY DURING TESTING AND PASSED ALL FUNCTIONAL TESTS. THE REPORTED FAULT COULD NOT BE REPLICATED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THEY ARE UNABLE TO ADJUST THE MAXIMUM PRESSURE ON AN RD900AFU NEOPUFF INFANT RESUSCITATOR. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOPUFF INFANT RESUSCITATOR BTL FISHER & PAYKEL HEALTHCARE LTD RD900AFU 090505

    Patients

    Seq Age Sex Outcome Treatment
    1