BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 2843312 · Received November 22, 2012

    Report

    Report Number
    9611451-2012-00847
    Event Type
    Malfunction
    Date Received
    November 22, 2012
    Report Date
    October 24, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: TWO COMPLAINT RD900 NEOPUFF INFANT RESUSCITATORS (LOT NUMBERS: DEVICE 1: 080107 AND DEVICE 2: 100112) WERE RETURNED TO OUR FISHER & PAYKEL HEALTHCARE (FPH) SERVICE CENTRE IN (B)(4). REPAIRS WERE CARRIED OUT AT THE (B)(4) OFFICE BY A TRAINED FPH SERVICE ENGINEER AND THEN THE REPLACED PARTS WERE RETURNED TO FPH IN (B)(4) FOR EVALUATION. RESULTS: VISUAL INSPECTION REVEALED THAT THE GAS OUTLET PORT WAS BROKEN AND THE ENCLOSURE WAS CRACKED ON BOTH DEVICES. THE PEAK INSPIRATORY PRESSURE VALVE ADJUSTMENT KNOB ON DEVICE 2 WAS ALSO BROKEN. A LOT CHECK DID NOT REVEAL ANY OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBERS 080107 AND 100112. 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. IN ADDITION THE NEOPUFF USER INSTRUCTIONS STATE THAT THE USER SHOULD "CHECK MANOMETER READS ZERO WITH NO GAS FLOW" AND CHECK THE PRESSURE SETTINGS "PRIOR TO EVERY USE OF THE NEOPUFF". IT IS MOST LIKELY THAT THE PHYSICAL DAMAGE OBSERVED ON THE NEOPUFF DEVICES WAS CAUSED BY SOME FORM OF IMPACT. THE FASCIA AND THE VALVE SYSTEMS ON BOTH THE NEOPUFF DEVICES WERE REPLACED AND THE DEVICES WERE THEN RETURNED TO THE CUSTOMER FACILITY AFTER PASSING THE NECESSARY SAFETY CHECKS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE GAS OUTLET CONNECTOR ON TWO RD900 NEOPFUFF INFANT RESUSCITATORS WERE BROKEN. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900AEU 080107

    Patients

    Seq Age Sex Outcome Treatment
    1