BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 2332625 · Received November 10, 2011

    Report

    Report Number
    9611451-2011-00699
    Event Type
    Malfunction
    Date Received
    November 10, 2011
    Report Date
    October 13, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT DEVICE WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION, ALTHOUGH THE CUSTOMER WAS ASKED TO RETURN THE FAULTY PART. RESULTS: THE CUSTOMER HAS INFORMED US THAT THE THEY HAVE REPLACED THE FAULTY MANOMETER WITH A WORKING SPARE PART AND HAVE DISCARDED THE FAULTY PART. WHEN ASKED THEY DID NOT SUPPLY US WITH ANY INFORMATION AS TO THE REPORTED FAULT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 090610. CONCLUSION: WHILE WE WERE UNABLE TO ASCERTAIN THE EXACT NATURE OF THE MANOMETER ISSUE, THE MOST COMMON CAUSE OF PROBLEMS WITH THE MANOMETER IS DAMAGE DUE TO THE NEOPUFF RECEIVING A SUBSTANTIAL IMPACT. THE NEOPUFF TECHNICAL MANUAL STATES THAT "DROPPING OF THE F&P 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 USER INSTRUCTIONS REQUIRE THAT THE NEOPUFF BE TESTED BY QUALIFIED PERSONNEL OR AN AUTHORISED FISHER & PAYKEL HEALTHCARE REPRESENTATIVE PRIOR TO EACH USE TO ENSURE FUNCTIONALITY. THE OPERATING MANUAL INSTRUCTS THE USER TO CARRY OUT A SET-UP PROCEDURE "PRIOR TO EVERY USE OF THE NEOPUFF TO ENSURE THAT THE DEVICE IS FUNCTIONING CORRECTLY." THE SET-UP PROCEDURE STATES THE USER MUST "CHECK MANOMETER READS ZERO WITH NO GAS FLOW. IF NOT, THE MANOMETER REQUIRES CALIBRATION" PER THE TECHNICAL MANUAL. IN ADDITION, THE NEOPUFF SET-UP PROCEDURE STATES THE USER MUST CHECK THE SETTINGS BY TESTING THE PRESSURE OUTPUT FROM THE NEOPUFF AT THE DESIRED FLOW RATE "PRIOR TO EVERY USE OF THE NEOPUFF TO ENSURE THAT THE DEVICE IS FUNCTIONING CORRECTLY."

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT THE MANOMETER OF AN RD900 INFANT RESUSCITATOR NEEDED REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900 090610

    Patients

    Seq Age Sex Outcome Treatment
    1