BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 1230839 · Received October 28, 2008

    Report

    Report Number
    9611451-2008-00630
    Event Type
    Malfunction
    Date Received
    October 28, 2008
    Report Date
    March 27, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PS27253. THE ACTUAL COMPLAINT DEVICE WAS VISUALLY INSPECTED FOR A BROKEN GAS INLET PORT. RESULTS: THE GAS INLET PORT OF THE NEOPUFF WAS BROKEN AND SNAPPED OFF FROM THE PANEL. STRESS MARK WAS VISIBLE AROUND THE CUT OFF AREA. IT WAS NOTICED THAT THE GAS SUPPLY LINE ADAPTOR WAS FULLY INSERTED INTO THE GAS INLET PORT CAUSING A TIGHT CONNECTION. THE SNAPPED OFF INLET PORT WAS STILL CONNECTED TO THE BROKEN GAS SUPPLY LINE WHEN THE NEOPUFF WAS INVESTIGATED. CONCLUSION: BECAUSE OF THE TIGHT CONNECTION, IT APPEARS THAT AN EXTRA AMOUNT OF FORCE WAS APPLIED TO DISCONNECT THE GAS SUPPLY LINE FROM THE GAS INLET PORT RESULTING IN SNAPPING OF THE INLET PORT. THE PORTS ON THE NEOPUFF USE A TAPERED FIT TO HOLD THE CONNECTING TUBES IN PLACE. REMOVAL OF THE GAS SUPPLY LINE FROM THE GAS INLET PORT OF THE NEOPUFF IS NORMALLY ACHIEVED BY CLASPING AND PULLING THE PLASTIC CONNECTOR AWAY FROM THE INLET PORT. IF THE GAS SUPPLY LINE IS FULLY INSERTED INTO THE GAS INLET PORT AND REMOVAL IS ATTEMPTED BY WAGGLING OR PULLING IT SIDEWAYS, IT COULD LEAD TO CRACKING OR SNAPPING OFF OF THE GAS INLET PORT AFTER MULTIPLE REUSES OF THE NEOPUFF.

    Description of Event or Problem · 1

    A HOSPITAL IN (B) (6) REPORTED THAT THE GAS INLET PORT OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR WAS BROKEN OFF. 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