BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 2537427 · Received April 17, 2012

    Report

    Report Number
    9611451-2012-00226
    Event Type
    Malfunction
    Date Received
    April 17, 2012
    Report Date
    March 20, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT (B)(4) NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO FPH SERVICE CENTRE IN (B)(4), WHERE IT WAS VISUALLY INSPECTED AND PERFORMANCE TESTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE GAS INLET PORT OF THE RETURNED NEOPUFF UNIT HAD BROKEN OFF, CONFIRMING THE FAULT REPORTED BY THE DISTRIBUTOR. 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 DISTRIBUTOR. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 101129. 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."

    Additional Manufacturer Narrative · 1

    (B)(4). THE RD900AGU NEOPUFF INFANT RESUSCITATOR IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVE THE COMPLAINT DEVICE AND HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT AN (B)(4) NEOPUFF INFANT RESUSCITATOR HAD A BROKEN GAS INLET PORT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT AN RD900AGU NEOPUFF INFANT RESUSCITATOR HAD A BROKEN GAS INLET PORT. 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 RD900AGU

    Patients

    Seq Age Sex Outcome Treatment
    1