BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 6252907 · Received January 15, 2017

    Report

    Report Number
    9611451-2017-00012
    Event Type
    Malfunction
    Date Received
    January 15, 2017
    Report Date
    January 4, 2017
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT 900IW130 NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO FPH SERVICE CENTER IN (B)(4), WHERE IT WAS INSPECTED BY A TRAINED FPH SERVICE MANAGER. OUR INVESTIGATION IS ACCORDINGLY BASED ON THE PHOTOGRAPHS AND SERVICE REPORT PROVIDED BY THE SERVICE MANAGER. RESULTS: THE FPH SERVICE MANAGER STATED THAT THE GAS OUTLET PORT OF THE SUBJECT NEOPUFF UNIT WAS BROKEN. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100909. 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. THE PHYSICAL DAMAGE OBSERVED WAS MOST LIKELY DUE TO IMPACT TO THE SUBJECT NEOPUFF UNIT. THE NEOPUFF TECHNICAL MANUAL STATES THE FOLLOWING: "DROPPING THE NEOPUFF 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." EACH NEOPUFF UNIT IS ASSEMBLED AND 100% TESTED IN THE PRODUCTION LINE TO VERIFY THAT EACH UNIT CONFORMS TO CRITICAL PRODUCT SPECIFICATIONS. ANY UNIT THAT FAILS IS REJECTED. THE SUBJECT NEOPUFF UNIT WAS DESTROYED AT FPH SERVICE CENTER, AS PER INSTRUCTIONS RECEIVED FROM THE DISTRIBUTOR.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT A 900IW130 NEOPUFF INFANT RESUSCITATOR, WHICH IS PART OF THE COSYCOT INFANT WARMER, WAS DEFECTIVE AND NEEDED REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35981 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LIMITED 900IW130

    Patients

    Seq Age Sex Outcome Treatment
    1