BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 4890426 · Received July 5, 2015

    Report

    Report Number
    9611451-2015-00304
    Event Type
    Malfunction
    Date Received
    July 5, 2015
    Report Date
    June 11, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT NEOPUFF WAS RECEIVED AT OUR REGIONAL OFFICE IN (B)(6), WHERE IT WAS INSPECTED BY A TRAINED FISHER & PAYKEL HEALTHCARE SERVICE ENGINEER. THE FASCIA AND VALVE SYSTEM WERE REPLACED AND THE NEOPUFF WAS RETURNED TO THE CUSTOMER AFTER A PERFORMANCE TEST. THE FAULTY COMPONENTS WERE SENT TO FISHER & PAYKEL HEALTHCARE (B)(6)FOR FURTHER INVESTIGATION. PHOTOGRAPHS OF THE SUBJECT NEOPUFF SHOWING THE DAMAGE WERE ALSO PROVIDED. RESULTS: VISUAL INSPECTION OF THE RETURNED NEOPUFF FASCIA AND VALVE SYSTEM REVEALED PHYSICAL DAMAGE IN THE FORM OF CRACKING TO THE GAS INLET PORT AND LOWER END CAPS THAT APPEARED TO BE THE RESULT OF AN IMPACT TO THE DEVICE. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT 131214. 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. 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 / 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 A NEOPUFF INFANT RESUSCITATOR GAS INLET VALVE WAS BROKEN AND REQUESTED SERVICE OF THE DEVICE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434255 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900 131214

    Patients

    Seq Age Sex Outcome Treatment
    1