BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 2917179 · Received January 15, 2013

    Report

    Report Number
    9611451-2013-00047
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Report Date
    December 18, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    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 (B)(4). REPAIRS WERE CARRIED OUT BY A TRAINED FPH SERVICE ENGINEER AND THEN THE REPLACED PARTS WERE RETURNED TO FPH IN (B)(4) FOR EVALUATION. RESULTS: VISUAL INSPECTION REVEALED THAT THE GAS OUTLET PORT WAS BROKEN ON THE RETURNED NEOPUFF INFANT RESUSCITATOR. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 111021. 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. IN ADDITION THE NEOPUFF USER INSTRUCTIONS STATE THAT THE USER SHOULD "CHECK MANOMETER READS ZERO WITH NO GAS FLOW" AND CHECK THE PRESSURE SETTINGS "PRIOR TO EVERY USE OF THE NEOPUFF". IT IS MOST LIKELY THAT THE PHYSICAL DAMAGE OBSERVED ON THE NEOPUFF DEVICE WAS CAUSED BY SOME FORM OF IMPACT. THE FASCIA AND THE VALVE SYSTEM ON THE NEOPUFF DEVICE WERE REPLACED AND THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FACILITY AFTER PASSING THE NECESSARY SAFETY CHECKS.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE GAS OUTLET CONNECTOR ON AN RD900 NEOPFUFF INFANT RESUSCITATOR WAS BROKEN. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23373 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900 111021

    Patients

    Seq Age Sex Outcome Treatment
    1