BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 2940406 · Received February 3, 2013

    Report

    Report Number
    9611451-2013-00071
    Event Type
    Malfunction
    Date Received
    February 3, 2013
    Report Date
    January 17, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT NEOPUFFS WERE RETURNED TO OUR REGIONAL OFFICE IN (B)(4). THE SECOND NEOPUFF HAD SERIAL NUMBER (B)(4), MANUFACTURE DATE FEBRUARY 20, 2004. THE NEOPUFFS WERE INSPECTED BY A TRAINED FISHER & PAYKEL HEALTHCARE SERVICE ENGINEER. THE MANOMETERS WERE VISUALLY INSPECTED AND PERFORMANCE TESTED. OUR INVESTIGATION IS BASED ON PHOTOGRAPHS AND SERVICE REPORTS PROVIDED BY THE US OFFICE. RESULTS: VISUAL INSPECTION REVEALED PHYSICAL DAMAGE TO THE END CAPS AND FASCIAE OF BOTH NEOPUFFS. PERFORMANCE TESTING REVEALED THAT BOTH MANOMETERS WERE OUT OF SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR EITHER LOT NUMBER. 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. IT MUST BE NOTED THAT BOTH NEOPUFFS HAVE BEEN IN SERVICE FOR ABOUT NINE YEARS. ALL MANOMETERS OF THE NEOPUFF UNITS ARE VISUALLY INSPECTED AND PERFORMANCE TESTED PRIOR TO LEAVING THE PRODUCTION LINE, AND THOSE THAT FAIL ARE REJECTED. 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". IN ADDITION THE NEOPUFF USER INSTRUCTIONS STATE THAT THE USER SHOULD "CHECK MANOMETER READS ZERO WITH NO GAS FLOW" AND CHECK THE PRESSURE SETTINGS "PRIOR TO EVERY USE OF THE NEOPUFF".

    Description of Event or Problem · 1

    A BIOMEDICAL TECHNICIAN AT A HOSPITAL IN (B)(6) REPORTED THAT THE HOUSING OF TWO NEOPUFF INFANT RESUSCITATORS WAS CRACKED AND THAT THE MANOMETERS WERE NOT ACCURATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45751 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900 030814

    Patients

    Seq Age Sex Outcome Treatment
    1