BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 3552511 · Received January 6, 2014

    Report

    Report Number
    9611451-2014-00003
    Event Type
    Malfunction
    Date Received
    January 6, 2014
    Report Date
    December 16, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RD900 NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO OUR FISHER & PAYKEL HEALTHCARE (FPH) SERVICE CENTRE IN THE US, WHERE IT WAS VISUALLY INSPECTED AND PERFORMANCE TESTED BY A TRAINED FPH SERVICE ENGINEER. OUR ANALYSIS IS BASED ON THE EVENT DESCRIPTION AND SERVICE REPORT PROVIDED BY THE FPH SERVICE ENGINEER. RESULTS: THE HEALTHCARE FACILITY REPORTED THAT THE PRESSURE ON THE SUBJECT NEOPUFF UNIT WAS NOT REACHING THE PROPER PRESSURE. UPON INSPECTION, IT WAS FOUND THAT THE VALVE SYSTEM WAS FAULTY. IT WAS ALSO OBSERVED THAT THE UPPER END CAP, THE LOWER END CAP AND THE FASCIA WERE BROKEN. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 090721. CONCLUSION: THE NEOPUFF IS A PORTABLE, REUSABLE DEVICE USED TO ASSIST IN THE DELIVERY OF RESPIRATORY BREATHS TO INFANTS UNTIL ADEQUATE SPONTANEOUS BREATHING OCCURS. BEING A PORTABLE DEVICE, THE NEOPUFF CAN BE SUSCEPTIBLE TO IMPACT DAMAGE, FOR INSTANCE WHEN ACCIDENTALLY DROPPED OR SUBJECTED TO CONSIDERABLE EXTERNAL FORCE. IT IS MOST LIKELY THAT THE DAMAGE OBSERVED TO THE NEOPUFF VALVE WAS DUE TO IMPACT. THE NEOPUFF TECHNICAL MANUAL STATES THE FOLLOWING: "DROPPING THE NEOPUFF INFANT RESUSCITATOR OR OTHER SIMILAR FORMS OF IMPACT MAY CAUSE DAMAGE RESULTING IN INCORRECT OPERATION OF THE UNIT. IF YOU SUSPECT DAMAGE TO HAVE OCCURRED, PLEASE PERFORM CHECKS AS OUTLINED [IN THE MANUAL] BEFORE CONNECTION TO A PATIENT." THE NEOPUFF UNIT WAS RETURNED TO THE HEALTHCARE FACILITY ONCE THE VALVE SYSTEM HAD BEEN REPLACED AND HAD PASSED THE PERFORMANCE TESTS SPECIFIED IN OUR NEOPUFF TECHNICAL MANUAL.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT AN RD900AFU NEOPUFF INFANT RESUSCITATOR WOULD NOT REACH THE CORRECT PRESSURE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6317 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LIMITED RD900 090721

    Patients

    Seq Age Sex Outcome Treatment
    1