BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 2064963 · Received April 20, 2011

    Report

    Report Number
    9611451-2011-00262
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE MANUFACTURE DATES: 04/02/2008, 06/03/2008, 06/26/2008. WE ARE CURRENTLY ENDEAVOURING TO OBTAIN FURTHER INFORMATION WITH REGARD TO THE COMPLAINT. WE WILL PROVIDE A FOLLOW UP REPORT UPON RECEIPT AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). SERIAL NUMBER: (B)(4) (LOT 080402), (B)(4) (LOT 080603), (B)(4) (LOT 080626). DEVICE MANUFACTURE DATE: 04/02/2008, 06/03/2008, 06/26/2008. METHOD: ONE COMPLAINT NEOPUFF WAS RETURNED AND HAD SERIAL NUMBER (B)(4) (LOT 080626). THE COMPLAINT DEVICE WAS VISUALLY INSPECTED AND PERFORMANCE TESTED. RESULTS: THE SET PRESSURE WAS SEEN TO FLUCTUATE WHEN LATERAL FORCE WAS APPLIED TO THE ADJUSTMENT KNOB, THUS FLEXING THE VALVE ASSEMBLY. IT WAS ALSO OBSERVED THAT THE PRESSURE SETTING RETURNED TO NORMAL WHEN THE FORCE WAS REMOVED AND THE CHANGES IN PRESSURE WERE DISPLAYED INSTANTLY ON THE NEOPUFF'S IN-BUILT MANOMETER. THE VISUAL INSPECTION REVEALED NO PHYSICAL DAMAGE TO THE DEVICE. THE MANOMETER AND VALVE SYSTEM OF THE RETURNED COMPLAINT NEOPUFF PASSED THE TESTS SPECIFIED IN THE NEOPUFF TECHNICAL MANUAL. HOWEVER FURTHER INVESTIGATION REVEALED THAT THE PRESSURE RISE WAS INCONSISTENT WHEN THE PEAK INSPIRATORY VALVE WAS ADJUSTED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 080626. A LOT CHECK REVEALED (B)(4) OTHER SIMILAR COMPLAINT OF THIS NATURE FOR LOT NUMBER 080603. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 080402. 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 TEST PERFORMED BY THE HOSPITAL BIOMED WAS NOT IN ACCORDANCE WITH TEST METHODS SPECIFIED IN THE NEOPUFF TECHNICAL MANUAL. IN THE UNLIKELY EVENT THAT INADVERTENT ADJUSTMENT OF THE PEAK INSPIRATORY PRESSURE (PIP) SETTING OCCURS (FOR EXAMPLE DURING RESUSCITATION) THE MAXIMUM ALLOWABLE PRESSURE IS CONTROLLED BY THE SETTING OF THE MAXIUMUM PRESSURE RELIEF VALVE. THE MAXIMUM PRESSURE RELIEF VALVE IS PROTECTED AGAINST INADVERTENT ADJUSTMENT BY THE MAXIMUM PRESSURE RELIEF COVER. 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" IN ADDITION TO THE SET-UP CHECKS, THE NEOPUFF 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 REPRESENTATIVE USING THE TESTS DESCRIBED IN THE MANUAL.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT DURING A MAINTENANCE CHECK THE "OUTPUT PRESSURE WILL DROP" WHEN THE STEM OF THE VALVE KNOB IS SLIGHTLY PUSHED ON THREE RD900 NEOPUFF INFANT RESUSCITATORS. NO PATIENT CONSEQUENCE WAS REPORTED AS THIS WAS FOUND DURING A MAINTENANCE CHECK.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT DURING A MAINTENANCE CHECK THE "OUTPUT PRESSURE WILL DROP" WHEN THE STEM OF THE VALVE KNOB IS SLIGHTLY PUSHED ON THREE RD900 NEOPUFF INFANT RESUSCITATORS. NO PATIENT CONSEQUENCE WAS REPORTED AS THIS WAS FOUND DURING A MAINTENANCE CHECK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1