BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 5465705 · Received February 28, 2016

    Report

    Report Number
    9611451-2016-00062
    Event Type
    Malfunction
    Date Received
    February 28, 2016
    Report Date
    January 20, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) PLEASE NOTE THIS REPORT WAS SUBMITTED ON 18 FEBRUARY 2016 BUT DUE TO AN ERROR WITH THE FDA GATEWAY THE THREE ACKNOWLEDGEMENTS WERE NOT RECEIVED. THIS REPORT IS BEING SUBMITTED AGAIN UPON RECOMMENDATION FROM THE CDRH. THE COMPLAINT DEVICE WAS RECENTLY RETURNED TO OUR OFFICE IN (B)(4), FOR INSPECTION. OUR INVESTIGATION IS CURRENTLY IN PROGRESS AND WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    METHOD: THE COMPLAINT RD900 INFANT RESUSCITATOR WAS RETURNED TO OUR SERVICE CENTER IN IRVINE, CALIFORNIA, WHERE IT WAS VISUALLY INSPECTED AND PERFORMANCE TESTED. RESULTS: VISUAL INSPECTION REVEALED CRACKS ON THE ENCLOSURE ON THE UPPER AND LOWER END CAPS. CRACKS WERE ALSO NOTED ON THE FASCIA AND VALVE ASSEMBLY. PERFORMANCE TEST REVEALED THAT THE MANOMETER WAS FAULTY. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 070816. 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 THE SUBJECT NEOPUFF IS OVER EIGHT YEARS OLD. ALL 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".

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6), REPORTED THAT AN RD900 NEOPUFF INFANT RESUSCITATOR DOES NOT READ THE CORRECT PRESSURE. THEY FURTHER REPORTED THAT THERE WAS PHYSICAL DAMAGE TO THE DEVICE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6), REPORTED THAT AN RD900 NEOPUFF INFANT RESUSCITATOR DOES NOT READ THE CORRECT PRESSURE. THEY FURTHER REPORTED THAT THERE WAS PHYSICAL DAMAGE TO THE DEVICE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122149 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900 070816

    Patients

    Seq Age Sex Outcome Treatment
    1