BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 1781261 · Received July 27, 2010

    Report

    Report Number
    9611451-2010-00454
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Report Date
    July 8, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT NEOPUFF WAS RETURNED TO FISHER & PAYKEL HEALTHCARE'S REGIONAL OFFICE AND SERVICE CENTER IN (B)(4). THE NEOPUFF WAS VISUALLY INSPECTED FOR DAMAGE AND WAS PERFORMANCE TESTED FOR FUNCTIONALITY. RESULTS: THE NEOPUFF WAS FOUND TO BE CRACKED AND FOUR SCREW COVERED WERE FOUND TO BE MISSING. THE MANOMETER WAS READING 22 CMH2O WITH NO FLOW APPLIED. WHEN THE UNIT WAS TESTED, THE MANOMETER READING FLUCTUATED DUE TO A LEAK IN THE VALVE ASSEMBLY. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 021121. CONCLUSION: THE NEOPUFF IS A PORTABLE, REUSABLE DEVICE USED TO ASSIST IN THE DELIVERY OF RESPIRATORY BREATHS TO INFANTS UNTIL ADEQUATE SPONTANEOUS BREATHING OCCURS. IT CAN BE SUSCEPTIBLE TO IMPACT DAMAGE, FOR INSTANCE WHEN ACCIDENTALLY DROPPED OR SUBJECTED TO CONSIDERABLE EXTERNAL FORCE. THE TECHNICAL MANUAL STATES THAT "DROPPING THE 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 PT." THE OPERATING INSTRUCTIONS STATE THAT THE SET-UP PROCEDURE, AS DESCRIBED IN THE INSTRUCTIONS, "SHOULD BE CARRIED OUT PRIOR TO EVERY USE OF THE NEOPUFF TO ENSURE THAT THE DEVICE IS FUNCTIONING CORRECTLY." THE PROCEDURE INCLUDES A CHECK OF THE DEVICE SETTINGS AND REQUIRES THE USER TO "CHECK MANOMETER READS ZERO WITH NO GAS FLOW." IN ADDITION, THE TECHNICAL MANUAL ADVISES THAT "THE INTEGRITY OF THE SYSTEM AND MANOMETER SHOULD BE CHECKED PRIOR TO FIRST USE, ANNUALLY AND AFTER SERVICING" BY QUALIFIED PERSONNEL OR AN AUTHORIZED FISHER & PAYKEL HEALTHCARE REP.

    Description of Event or Problem · 1

    A MEDICAL CENTER IN (B)(6) REPORTED THAT AN RD900 NEOPUFF INFANT RESUSCITATOR'S "CIRCUIT PRESSURE WILL NOT ADJUST." NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOPUFF INFANT RESUSCITATOR BTL FISHER & PAYKEL HEALTHCARE, LTD. RD900AEU 021121

    Patients

    Seq Age Sex Outcome Treatment
    1