BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAS SUPPLY LINE

    MDR report key: 4221574 · Received November 3, 2014

    Report

    Report Number
    9611451-2014-00843
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 10, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE 900RD009 GAS SUPPLY LINE WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: INSPECTION REVEALED THAT THE FLEXIBLE TUBING OF THE COMPLAINT GAS SUPPLY LINE IS TORN NEXT TO THE 6MM ADAPTOR. CONCLUSION: THE NEOPUFF GAS SUPPLY LINE IS A REUSABLE DEVICE AND CONSISTS OF FLEXIBLE TUBING WITH A PLASTIC CONNECTOR AT ONE END. THE PLASTIC CONNECTOR FITS TO THE INLET PORT OF THE NEOPUFF. REMOVAL OF THE GAS SUPPLY LINE FROM THE NEOPUFF INLET PORT IS NORMALLY ACHIEVED BY CLASPING AND PULLING THE PLASTIC CONNECTOR AWAY FROM THE INLET PORT. IF REMOVAL IS ATTEMPTED BY PULLING ON THE GAS SUPPLY LINE TUBING INSTEAD, IT COULD LEAD TO WEAKENING AND TEARING OF THE REUSABLE TUBE AT THE TUBE-CONNECTOR INTERFACE AFTER MULTIPLE REUSES. THE NEOPUFF INFANT RESUSCITATOR USER INSTRUCTIONS STATE THE FOLLOWING: PRIOR TO EVERY USE OF THE NEOPUFF, THE USER IS TO ENSURE THAT THE DEVICE IS FUNCTIONING CORRECTLY AND THAT THE PEEP CAP IS ADJUSTED TO THE DESIRED PEEP LEVEL. THE NEOPUFF INFANT RESUSCITATOR MUST ONLY BE USED AFTER CHECKING THAT CORRECT PRESSURES WILL BE DELIVERED TO THE BABY.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE GAS SUPPLY TUBING USED WITH THE NEOPUFF INFANT RESUSCITATOR HAD A HOLE IN IT AFTER A MONTH OF USE.NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703345 GAS SUPPLY LINE BTL BTL FISHER & PAYKEL HEALTHCARE LTD 900RD009

    Patients

    Seq Age Sex Outcome Treatment
    1