BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 2176321 · Received July 25, 2011

    Report

    Report Number
    9611451-2011-00437
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Report Date
    June 24, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    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

    METHOD: THE COMPLAINT RD900AFU NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO FPH SERVICE CENTRE IN (B)(6). OUR ANALYSIS IS BASED ON THE SERVICE REPORT PROVIDED BY THE SERVICE CENTRE. RESULTS: A VISUAL INSPECTION REVEALED THAT THE MANOMETER NEEDLE OF THE RETURNED NEOPUFF UNIT WAS STUCK. THE NEEDLE WAS FREED FROM STICKING BY USING THE ZERO ADJUSTMENT SCREW OF THE MANOMETER. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 030623. CONCLUSION: THE FPH SERVICE CENTRE IN (B)(4) WAS NOT ABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED FAULT, AS THE AFFECTED NEOPUFF UNIT FUNCTIONED NORMALLY AFTER THE PROBLEM WITH THE MANOMETER NEEDLE HAD BEEN FIXED. THE NEOPUFF TECHNICAL MANUAL STATES: "DROPPING OF THE F&P NEOPUFF INFANT RESUSCITATOR OR OTHER SIMILAR FORMS OF IMPACT MAY CAUSE DAMAGE RESULTING IN INCORRET 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 AUTHORIZED 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. THE NEOPUFF SET-UP PROCEDURE ALSO 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". THE NEOPUFF UNIT WAS RETURNED TO THE HEALTHCARE FACILITY AFTER IT HAD BEEN SERVICED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RD900AFU NEOPUFF INFANT RESUSCITATOR WAS RETURNED AND SERVICED AT THE FISHER & PAYKEL HEALTHCARE (FPH) SERVICE CENTER IN (B)(4). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION IN ORDER TO ASSIST US WITH THE ANALYSIS AND IDENTIFICATION OF A POSSIBLE ROOT CAUSE OF THE EVENT AS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE MANOMETER NEEDLE OF AN RD900AFU NEOPUFF INFANT RESUSCITATOR WAS STUCK AFTER USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE MANOMETER NEEDLE OF AN RD900AFU NEOPUFF INFANT RESUSCITATOR WAS STUCK AFTER USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LIMITED RD900AFU

    Patients

    Seq Age Sex Outcome Treatment
    1