BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 4050550 · Received September 1, 2014

    Report

    Report Number
    9611451-2014-00742
    Event Type
    Malfunction
    Date Received
    September 1, 2014
    Report Date
    August 4, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RD900 NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO OUR FISHER & PAYKEL HEALTHCARE (FPH) REGIONAL OFFICE IN (B)(4), WHERE IT WAS INSPECTED BY A TRAINED FPH TECHNICIAN. RESULTS: VISUAL INSPECTION OF THE NEOPUFF REVEALED THAT THE GAS INLET PORT WAS BROKEN. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS TYPE FOR LOT NUMBER 070817. 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 PHYSICAL DAMAGE TO THE GAS INLET PORT, CASING AND MANOMETER WAS CAUSED BY SOME SORT OF 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."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE GAS INLET PORT OF A NEOPUFF INFANT RESUSCITATOR WAS BROKEN AND REQUESTED A PERFORMANCE CHECK. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531622 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900 070817

    Patients

    Seq Age Sex Outcome Treatment
    1