BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 3920984 · Received July 9, 2014

    Report

    Report Number
    9611451-2014-00607
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 12, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RD900 NEOPUFF RESUSCITATOR WAS RETURNED TO OUR SERVICE CENTRE IN (B)(4) WHERE IT WAS VISUALLY INSPECTED. THE DAMAGED COMPONENTS WERE THEN SENT TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR FURTHER INVESTIGATION. RESULTS: VISUAL INSPECTION REVEALED THAT THE GAS INLET PORT WAS CRACKED AND THE GAS OUTLET PORT WAS BROKEN ON THE RETURNED NEOPUFF DEVICE. THE UPPER END CAP WAS ALSO BROKEN. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT 030623. 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 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 COMPLAINT NEOPUFF DEVICE WAS FITTED WITH A NEW FASCIA, VALVE SYSTEM AND END CAP. THE NEOPUFF WAS RETURNED TO THE CUSTOMER AFTER PASSING THE SAFETY AND PERFORMANCE TESTS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE GAS INLET & OUTLET PORTS OF AN RD900 NEOPUFF INFANT RESUSCITATOR WERE BROKEN. A SERVICE OF THE DEVICE WAS REQUESTED.NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE GAS INLET AND OUTLET PORTS OF AN RD900 NEOPUFF INFANT RESUSCITATOR WERE BROKEN. A SERVICE OF THE DEVICE WAS REQUESTED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401203 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900 030623

    Patients

    Seq Age Sex Outcome Treatment
    1