BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 3321038 · Received September 2, 2013

    Report

    Report Number
    9611451-2013-00656
    Event Type
    Malfunction
    Date Received
    September 2, 2013
    Date of Event
    August 5, 2013
    Report Date
    August 5, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT NEOPUFF WAS RETURNED TO OUR FACILITY IN (B)(4), WHERE IT WAS INSPECTED AND REPAIRED BY A TRAINED FISHER & PAYKEL HEALTHCARE SERVICE ENGINEER. OUR INVESTIGATION IS BASED ON A PHOTOGRAPH AND SERVICE REPORT PROVIDED BY OUR US OFFICE. RESULTS: VISUAL INSPECTION OF THE SUBJECT NEOPUFF REVEALED PHYSICAL DAMAGE TO THE GAS OUTLET PORT THAT APPEARED TO BE THE RESULT OF AN IMPACT TO THE DEVICE. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR A BROKEN OUTLET PORT FOR LOT 120928. 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." THE FASCIA AND VALVE SYSTEM WAS REPLACED AND THE NEOPUFF WAS RETURNED TO THE CUSTOMER AFTER IT PASSED ALL PERFORMANCE AND SAFETY TESTS AS PER THE NEOPUFF TECHNICAL MANUAL.

    Description of Event or Problem · 1

    A BIOMEDICAL ENGINEER AT A HOSPITAL IN (B)(6) REPORTED THAT THE GAS OUTLET PORT OF A NEOPUFF INFANT RESUSCITATOR WAS DAMAGED AND REQUESTED A REPAIR. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433788 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900 120928

    Patients

    Seq Age Sex Outcome Treatment
    1