BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 1982112 · Received February 8, 2011

    Report

    Report Number
    9611451-2011-00050
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. A FISHER & PAYKEL HEALTHCARE SERVICE ENGINEER AT OUR REGIONAL OFFICE IN (B)(4) HAS VISUALLY INSPECTED THE COMPLAINT DEVICE AND ATTEMPTED TO RESET THE MANOMETER. RESULTS: THE VISUAL INSPECTION REVEALED THAT THE MANOMETER NEEDLE INDICATOR IS STUCK AT APPROXIMATELY 80CMH2O. WHEN AN ATTEMPT TO ADJUST THE MANOMETER SETTINGS TO ZERO, IT COULD NOT BE RESET. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: STUCK MANOMETER NEEDLES ARE GENERALLY ASSOCIATED WITH NEOPUFF UNITS THAT HAVE BEEN DROPPED OR IMPACTED. 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." FURTHERMORE, THE NEOPUFF TECHNICAL MANUAL STATES THE FOLLOWING: "THE INTEGRITY OF THE SYSTEM AND MANOMETER SHOULD BE CHECKED PRIOR TO FIRST USE, ANNUAL AND AFTER SERVICING"; "WARNING DROPPING OF THE F&P 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."

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT THE MANOMETER OF AN RD900 NEOPUFF INFANT RESUSCITATOR MALFUNCTIONED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900AEU 100217

    Patients

    Seq Age Sex Outcome Treatment
    1