BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 3885090 · Received June 19, 2014

    Report

    Report Number
    9611451-2014-00542
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 21, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE FAULTY FASCIA AND VALVE SYSTEM OF THE COMPLAINT NEOPUFF WERE RECEIVED AT FISHER & PAYKEL HEALTHCARE (B)(4). THE DEVICE WAS VISUALLY INSPECTED AND THEN TESTED. RESULTS: VISUAL INSPECTION OF THE SUBJECT NEOPUFF REVEALED THAT THE GAS INLET PORT HAS COME OFF THE FRONT FASCIA (IT WAS NOT RETURNED). THERE WAS EVIDENCE THAT THE GAS INLET PORT HAD BEEN GLUED TO THE FRONT PANEL. THE GAS OUTLET PORT WAS GLUED TO THE FRONT PANEL. BOTH ELBOWS WERE GLUED TO THE MANIFOLD BUT NOT TO THE GAS INLET AND OUTLET PORTS. THE COMPLAINT NEOPUFF PASSED THE PERFORMANCE TEST WHEN FITTED WITH A WORKING MANOMETER AND A REPLACEMENT GAS INLET PORT. CONCLUSION: THE ELBOWS WERE NOT GLUED TO THE GAS INLET AND OUTLET PORTS. THIS IS OUT OF SPECIFICATION. THE BROKEN INLET PORT WAS LIKELY THE RESULT OF PHYSICAL IMPACT. THE ABSENCE OF GLUE ON THE ELBOWS WAS CAUSED BY FAILURE OF PRODUCTION LINE STAFF TO APPLY GLUE TO THE GAS INLET AND OUTLET PORTS BEFORE FITTING THE ELBOWS. THIS IS THE ONLY FAILURE OF THIS NATURE THAT WE HAVE SEEN IN THE NEOPUFF. THE FASCIA AND VALVE SYSTEM WERE REPLACED AND THE SUBJECT NEOPUFF WAS RETURNED TO THE CUSTOMER AFTER IT HAS PASSED ALL PERFORMANCE AND SAFETY TESTS AS PER THE NEOPUFF TECHNICAL MANUAL.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FAULTY COMPONENTS OF THE COMPLAINT NEOPUFF HAVE BEEN RECEIVED AT FISHER & PAYKEL HEALTHCARE (B)(4) AND ARE CURRENTLY BEING EVALUATED. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A BIOMEDICAL ENGINEER AT A HOSPITAL IN AUSTRALIA REPORTED THAT THE LEFT HAND CONNECTOR OF A NEOPUFF INFANT RESUSCITATOR CAME OFF WHEN THE GAS SUPPLY TUBE WAS PULLED OFF. THEY REQUESTED A REPAIR OF THE DEVICE.

    Description of Event or Problem · 1

    A BIOMEDICAL ENGINEER AT A HOSPITAL IN (B)(6) REPORTED THAT THE LEFT HAND CONNECTOR OF A NEOPUFF INFANT RESUSCITATOR CAME OFF WHEN THE GAS SUPPLY TUBE WAS PULLED OFF. THEY REQUESTED A REPAIR OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360626 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900 130628

    Patients

    Seq Age Sex Outcome Treatment
    1