BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 2429746 · Received January 26, 2012

    Report

    Report Number
    9611451-2012-00037
    Event Type
    Malfunction
    Date Received
    January 26, 2012
    Date of Event
    November 28, 2011
    Report Date
    November 28, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RD900AEU NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) SERVICE CENTRE IN (B)(4), WHERE IT WAS VISUALLY INSPECTED AND PERFORMANCE TESTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE GAS OUTLET PORT OF THE RETURNED NEOPUFF UNIT WAS BROKEN OFF, CONFIRMING THE FAULT REPORTED BY THE HOSPITAL. THE FACIA AND VALVE ASSEMBLY WERE REPLACED AND THE NEOPUFF UNIT WAS TESTED IN ACCORDANCE WITH THE NEOPUFF TECHNICAL MANUAL. THE UNIT PASSED THE PERFORMANCE CHECKS AND WAS RETURNED TO THE HOSPITAL TO BE PUT BACK INTO SERVICE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 070630. CONCLUSION: THE NEOPUFF IS A PORTABLE, REUSABLE DEVICE USED TO ASSIST IN THE DELIVERY OF RESPIRATORY BREATHS TO INFANT 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. IT IS MOST LIKELY THAT THE DAMAGE TO THE NEOPUFF GAS INLET PORT WAS DUE TO IMPACT. THE NEOPUFF TECHNICAL MANUAL STATES THE FOLLOWING: "DROPPING THE NEOPUFF/PERIVENT 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." NEW FASCIA AND VALVE ASSEMBLY WERE FITTED AND THE UNIT IS BACK IN USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) THAT THE GAS OUTLET PORT OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR WAS DAMAGED. THIS WAS NOTICED DURING 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 BTL FISHER & PAYKEL HEALTHCARE LIMITED RD900AEU 070630001635

    Patients

    Seq Age Sex Outcome Treatment
    1