BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 2435618 · Received February 1, 2012

    Report

    Report Number
    9611451-2012-00036
    Event Type
    Malfunction
    Date Received
    February 1, 2012
    Date of Event
    January 4, 2012
    Report Date
    January 6, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT NEOPUFF UNIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) SERVICE CENTRE IN (B)(4), WHERE IT WAS VISUALLY INSPECTED AND PERFORMANCE CHECKED. THE DEFECTIVE MANOMETER WAS EVENTUALLY FORWARDED TO FPH (B)(4) FOR FURTHER INSPECTION. RESULTS: NO PHYSICAL DAMAGE WAS OBSERVED WITH THE RETURNED NEOPUFF UNIT. THE MANOMETER NEEDLE WAS STICKING DURING THE PERFORMANCE CHECKS, CONFIRMING THE FAULT REPORTED BY THE HEALTHCARE FACILITY. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100930. 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. IT IS MOST LIKELY THAT THE FAULT TO THE MANOMETER NEEDLE WAS DUE TO IMPACT. 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". THE FPH SERVICE CENTRE RETURNED THE NEOPUFF DEVICE TO THE HEALTHCARE FACILITY AFTER THE MANOMETER WAS REPLACED, AND THE UNIT PASSED THE PERFORMANCE CHECKS.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE MANOMETER NEEDLE OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR WAS STICKING. THIS WAS NOTICED PRIOR TO PATIENT USE.

    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