BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 5222078 · Received November 13, 2015

    Report

    Report Number
    9611451-2015-00477
    Event Type
    Malfunction
    Date Received
    November 13, 2015
    Date of Event
    October 14, 2015
    Report Date
    October 15, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT NEOPUFF WAS RECEIVED AT FISHER & PAYKEL HEALTHCARE (FPH) SERVICE CENTER IN THE UNITED STATES. OUR INVESTIGATION IS BASED ON THE SERVICE FINDINGS AND A PHOTOGRAPH PROVIDED. RESULTS: VISUAL INSPECTION OF THE PHOTOGRAPH OF THE SUBJECT NEOPUFF REVEALED THAT THE GAS OUTLET PORT OF THE COMPLAINT NEOPUFF UNIT WAS BROKEN. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 140328. CONCLUSION: THE NEOPUFF IS A PORTABLE, REUSABLE DEVICE USED TO ASSIST IN THE DELIVERY OF RESPIRATORY BREATHS TO INFANT 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. ALL NEOPUFF UNITS ARE VISUALLY INSPECTED AND PERFORMANCE TESTED BEFORE LEAVING THE PRODUCTION LINE AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE SUBJECT NEOPUFF UNIT WAS DAMAGED AFTER IT WAS RELEASED FOR DISTRIBUTION. IT IS MOST LIKELY THAT THE PHYSICAL DAMAGE TO THE GAS OUTLET PORT 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. THE FASCIA AND VALVE SYSTEM WERE REPLACED AT THE FPH SERVICE CENTER, AND THE SUBJECT NEOPUFF WAS RETURNED TO THE HEALTHCARE FACILITY AFTER PASSING THE PERFORMANCE CHECK SPECIFIED IN THE NEOPUFF TECHNICAL MANUAL.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE GAS OUTLET PORT OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR WAS BROKEN. SERVICE WAS REQUESTED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753170 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900 140328

    Patients

    Seq Age Sex Outcome Treatment
    1