BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 4212156 · Received October 29, 2014

    Report

    Report Number
    9611451-2014-00833
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 30, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT NEOPUFFS WERE NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. OUR INVESTIGATION IS BASED ON INFORMATION PROVIDED BY THE CUSTOMER. THE SECOND COMPLAINT NEOPUFF HAD SERIAL NUMBER (B)(4) AND WAS MANUFACTURED ON MAY 8, 2013. RESULTS: UPON RECEIPT OF THIS COMPLAINT FURTHER INFORMATION WAS SOUGHT FROM THE CUSTOMER CONCERNING THE CAUSE OF THE REPORTED DAMAGE. WE WERE THEN INFORMED THAT THE NEOPUFFS WERE NOT DROPPED, BUT WERE USED QUITE OFTEN AND THE NURSES HAVE HAD TO CONNECT AND REMOVE PATIENT CIRCUITS MANY TIMES. 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. 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 HOSPITAL BIOMED INFORMED US THAT AN EMAIL HAS BEEN SENT TO HOSPITAL CLINICAL LEADERSHIP ADVISING MORE CARE WHEN REMOVING THE TUBING FROM THE NEOPUFF TO PREVENT FUTURE OCCURRENCE OF THIS PROBLEM.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE GAS OUTLET PORTS OF TWO NEOPUFF INFANT RESUSCITATORS WERE BROKEN. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691586 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900 131011

    Patients

    Seq Age Sex Outcome Treatment
    1