BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 2103247 · Received May 25, 2011

    Report

    Report Number
    9611451-2011-00312
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 3, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT 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.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE FASCIA AND THE VALVE SYSTEM OF THE COMPLAINT RD900AEU NEOPUFF INFANT RESUSCITATOR WERE RETURNED TO FPH (B)(4) FOR INSPECTION. THE VALVE SYSTEM WAS FITTED WITH A TEST MANOMETER AND PERFORMANCE TESTED BASED ON THE NEOPUFF TECHNICAL MANUAL. THE PIP VALVE WAS CHECKED FOR VIBRATION BY APPLYING DIFFERENT GAS FLOW RATES. RESULTS: THE RETURNED VALVE SYSTEM PASSED THE PERFORMANCE TEST SPECIFIED IN THE NEOPUFF TECHNICAL MANUAL; HOWEVER, THE PIP VALVE FAILED THE VIBRATION TEST. IT WAS NOTED TO BE NOISY AT CERTAIN PRESSURES AND AT DIFFERENT GAS FLOW RATES, CONFIRMING THE REPORTED FAULT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 110223. 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. WE WERE UNABLE TO DETERMINE WHAT CAUSED THE FAULT OBSERVED BY THE HOSPITAL. ALL NEOPUFF UNITS ARE PERFORMANCE TESTED, INCLUDING VALVE VIBRATION MONITORING, PRIOR TO LEAVING THE PRODUCTION LINE AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE VALVE BECAME DEFECTIVE POST PRODUCTION. IT IS MOST LIKELY THAT THE NEOPUFF HAS BEEN SUBJECTED TO IMPACT DURING TRANSPORTATION WITHOUT INCURRING ANY PHYSICAL DAMAGE, WHICH COULD HAVE CONTRIBUTED TO THE REPORTED FAULT. 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". A REPLACEMENT VALVE ASSEMBLY KIT HAS BEEN SUPPLIED TO THE HOSPITAL.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE VALVE ASSEMBLY OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR MADE A LOUD VIBRATING NOISE WHEN THE PEAK INSPIRATORY PRESSURE (PIP) VALVE WAS ADJUSTED. THIS WAS NOTICED PRIOR TO PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE VALVE ASSEMBLY OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR MADE A LOUD VIBRATING NOISE WHEN THE PEAK INSPIRATORY PRESSURE (PIP) WAS ADJUSTED. THIS WAS NOTICED PRIOR TO PATIENT USE. 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