BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 1854604 · Received September 9, 2010

    Report

    Report Number
    9611451-2010-00533
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 16, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED NEOPUFF DEVICE WAS VISUALLY INSPECTED FOR A BROKEN PORT AND OTHER EXTERNAL DAMAGE. RESULTS: THE HOSPITAL REPORTED THAT THE GAS INLET PORT OF THE NEOPUFF DEVICE HAD BROKEN OFF. INSPECTION OF COMPLAINT DEVICE REVEALED THAT THE SAID PORT APPEARED TO HAVE SHEARED OFF ITS MANIFOLD. NO OTHER DAMAGE WAS OBSERVED. 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. THE HOSPITAL STAFF CONFIRMED THAT THE GAS INLET PORT OF THE NEOPUFF HAD BROKEN OFF DUE TO IMPACT. A BROKEN GAS INLET PORT WILL RENDER THE NEOPUFF DEVICE UNUSABLE. THE NEOPUFF UNIT WAS PUT INTO HOSPITAL SERVICE AFTER THE PANEL AND VALVE ASSEMBLY WERE REPLACED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) CUSTOMER CARE SPECIALIST IN OUR (B)(4) OFFICE THAT THE GAS INLET PORT OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR HAD BROKEN OFF. THIS WAS NOTICED AFTER USE ON A PATIENT. NO PATIENT 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