BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 1883664 · Received October 26, 2010

    Report

    Report Number
    9611451-2010-00641
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 30, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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 RETURNED RD900AEU NEOPUFF INFANT RESUSCITATOR WAS VISUALLY INSPECTED FOR DAMAGE. THE MANOMETER AND PEAK INSPIRATORY PRESSURE (PIP) VALVE WERE PERFORMANCE TESTED FOR THE ACCURACY OF ITS PRESSURE READINGS. RESULTS: THERE WAS NO PHYSICAL DAMAGE NOTED TO THE NEOPUFF UNIT. THE REPORTED FAULT COULD NOT BE REPLICATED AS BOTH THE MANOMETER AND THE PIP VALVE FUNCTIONED PROPERLY DURING PERFORMANCE TESTING. CONCLUSION: NO FAULT WAS FOUND WITH THE NEOPUFF AS IT OPERATED PROPERLY DURING TESTING. BOTH THE NEOPUFF USER INSTRUCTIONS AND THE NEOPUFF TECHNICAL MANUAL DESCRIBE THE SET-UP PROCEDURE FOR THE DEVICE INCLUDING HOW TO CHECK AND ADJUST THE SETTINGS PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) CUSTOMER CARE SPECIALIST IN OUR US OFFICE THAT THE PEAK INSPIRATORY PRESSURE (PIP) KNOB OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR IS "LOOSE AND JUMPS AROUND A LOT." THIS WAS NOTICED BEFORE USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) CUSTOMER CARE SPECIALIST IN OUR US OFFICE THAT THE PEAK INSPIRATORY PRESSURE (PIP) KNOB OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR IS "LOOSE AND JUMPS AROUND A LOT". THIS WAS NOTICED BEFORE USE ON A PATIENT. 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