BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 4021502 · Received August 19, 2014

    Report

    Report Number
    9611451-2014-00719
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Report Date
    August 4, 2014
    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 (B)(4) NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO FPH SERVICE CENTRE IN (B)(4), WHERE IT WAS INSPECTED BY A TRAINED FISHER & PAYKEL HEALTHCARE TECHNICIAN. OUR INVESTIGATION IS BASED ON A PHOTOGRAPH AND SERVICE INFORMATION PROVIDED BY OUR REGIONAL OFFICE. RESULTS: VISUAL INSPECTION OF THE RETURNED NEOPUFF UNIT REVEALED THAT THE GAS OUTLET PORT WAS BROKEN. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF A SIMILAR NATURE FOR LOT NUMBER 090907. 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 NEOPUFF TECHNICAL MANUAL WARNS AGAINST DROPPING THE NEOPUFF OR SUBJECTING IT TO IMPACT DAMAGE WHICH MAY CAUSE THE UNIT TO OPERATE INCORRECTLY. IF THE NEOPUFF IS SUSPECTED TO HAVE BEEN DAMAGED, THE MANOMETER AND VALVE SYSTEM SHOULD BE PERFORMANCE TESTED. 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." THE FASCIA AND VALVE SYSTEM HAVE BEEN REPLACED AND THE NEOPUFF WAS RETURNED TO THE CUSTOMER AFTER IT HAS PASSED ALL PERFORMANCE AND SAFETY TESTS AS PER THE NEOPUFF TECHNICAL MANUAL. EVALUATED BY FPH SERVICE CENTRE (B)(6).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(4) REPORTED THAT THE GAS OUTLET PORT OF A NEOPUFF INFANT RESUSCITATOR WAS BROKEN AND REQUESTED A REPAIR.NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497869 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LIMITED RD900 090907

    Patients

    Seq Age Sex Outcome Treatment
    1