BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 5122846 · Received October 2, 2015

    Report

    Report Number
    9611451-2015-00427
    Event Type
    Malfunction
    Date Received
    October 2, 2015
    Date of Event
    September 2, 2015
    Report Date
    September 2, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS RECENTLY RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. OUR INVESTIGATION IS CURRENTLY IN PROGRESS AND WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT DEVICE WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. IT WAS VISUALLY INSPECTED AND THE VALVE SYSTEM WAS PERFORMANCE TESTED. RESULTS: VISUAL INSPECTION REVEALED THAT TUBE FROM THE MANIFOLD TO THE MANOMETER INLET PORT WAS FOUND DETACHED. PERFORMANCE OF THE VALVE SYSTEM REVEALED THAT IT WAS WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 150127. CONCLUSION: THE NEOPUFF IS ASSEMBLED AND 100% TESTED ON THE PRODUCTION LINE TO VERIFY THAT EACH NEOPUFF PRODUCT CONFORMS TO CRITICAL PRODUCT SPECIFICATIONS. ALL NEOPUFFS ARE VISUALLY INSPECTED AND PERFORMANCE TESTED PRIOR TO LEAVING THE PRODUCTION LINE, AND THOSE THAT FAIL ARE REJECTED. 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 OPERATION OF THE F&P NEOPUFF / PERIVENT MUST BE CHECKED PRIOR TO FIRST USE. THE DEVICE MUST NOT BE USED ON UNATTENDED PATIENTS. ADDITIONALLY, THE NEOPUFF USER INSTRUCTIONS STATE: CHECK MANOMETER READS ZERO WITH NO GAS FLOW. CHECK THE PRESSURE SETTINGS PRIOR TO EVERY USE OF THE NEOPUFF. THE NEOPUFF INFANT RESUSCITATOR MUST ONLY BE USED AFTER CHECKING THAT CORRECT PRESSURES WILL BE DELIVERED TO THE BABY. AN ALTERNATIVE MEANS OF RESUSCITATION MUST BE AVAILABLE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT DURING INSTALLATION THE 900IW130E NEOPUFF RESUSCITATOR WAS NOT DELIVERING ANY PRESSURE. THEY FURTHER REPORTED THAT THE MANOMETER INLET TUBE WAS NOT SECURELY CONNECTED. THIS WAS FOUND DURING SET UP AND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT DURING INSTALLATION THE 900IW130E NEOPUFF RESUSCITATOR WAS NOT DELIVERING ANY PRESSURE. THEY FURTHER REPORTED THAT THE MANOMETER INLET TUBE WAS NOT SECURELY CONNECTED. THIS WAS FOUND DURING SET UP AND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654741 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD 900IW130E 150127

    Patients

    Seq Age Sex Outcome Treatment
    1