BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 2070049 · Received April 26, 2011

    Report

    Report Number
    9611451-2011-00265
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 28, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MANOMETER OF (B)(4) NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4). IT WAS VISUALLY INSPECTED FOR DAMAGE AND PERFORMANCE TESTED FOR FUNCTIONALITY. RESULTS: NO PHYSICAL DAMAGES WERE OBSERVED ON THE RETURNED MANOMETER. WHEN THE MANOMETER WAS ATTACHED TO A TEST VALVE ASSEMBLY, THE NEEDLE WAS STUCK AT 16 CMH2O. AN ATTEMPT WAS MADE TO ADJUST THE MANOMETER SETTING TO ZERO BUT IT COULD NOT BE RESET. CONCLUSION: THE FAULT OBSERVED WAS DUE TO THE MISALIGNMENT OF THE MANOMETER INTERNAL MECHANISM. THE NEOPUFF IS A PORTABLE, REUSABLE DEVICE USED TO ASSIST IN THE DELIVERY OF RESPIRATORY BREATHS TO INFANTS UNTIL ADEQUATE SPONTANEOUS BREATHING OCCURS. THE OPERATING MANUAL INSTRUCTS THE USER TO CARRY OUT A SET-UP PROCEDURE "PRIOR TO EVERY USE OF THE NEOPUFF TO ENSURE THAT THE DEVICE IS FUNCTIONING CORRECTLY". THE SET-UP PROCEDURE STATES THE USER MUST CHECK THE SETTINGS BY TESTING THE PRESSURE OUTPUT FROM THE NEOPUFF AT THE DESIRED FLOW RATE. THE NEOPUFF TECHNICAL MANUAL ALSO STATES THE FOLLOWING: "THE INTEGRITY OF THE SYSTEM AND MANOMETER SHOULD BE CHECKED PRIOR TO FIRST USE, ANNUAL AND AFTER SERVICING". "WARNING DROPPING OF THE F&P NEOPUFF 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 RD900AEU 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 MEDICAL CENTER IN (B)(6) REPORTED THAT THE MANOMETER OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR WAS STICKING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A MEDICAL CENTER IN (B)(6) REPORTED THAT THE MANOMETER OF AN (B)(4) NEOPUFF INFANT RESUSCITATOR WAS STICKING. 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

    Patients

    Seq Age Sex Outcome Treatment
    1