BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 1905286 · Received November 22, 2010

    Report

    Report Number
    9611451-2010-00708
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RD900AWU NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO FPH SERVICE CENTER IN (B)(4) FOR INSPECTION. IT WAS VISUALLY INSPECTED FOR DAMAGE AND PERFORMANCE TESTED FOR THE REPORTED FAULT. RESULTS: THE REPORTED FAULT COULD NOT BE REPLICATED AS THE VALVE SYSTEM AND THE MANOMETER OPERATED PROPERLY DURING PERFORMANCE TESTING. HOWEVER, VISUAL INSPECTION SHOWED THAT THE GAS INLET CONNECTOR WAS BROKEN AND THE NEOPUFF CASING WAS CRACKED. CONCLUSION: THE NEOPUFF IS A PORTABLE, REUSABLE DEVICE USED TO ASSIST IN THE DELIVERY OF RESPIRATORY BREATHS TO INFANTS UNTIL ADEQUATE SPONTANEOUS BREATHING OCCURS. IT CAN BE SUSCEPTIBLE TO IMPACT DAMAGE, FOR INSTANCE WHEN ACCIDENTALLY DROPPED OR SUBJECTED TO CONSIDERABLE EXTERNAL FORCE. THE NEOPUFF USER INSTRUCTIONS STATE THAT THE USER SHOULD "CHECK MANOMETER READS ZERO WITH NO GAS FLOW" AND CHECK THE PRESSURE SETTINGS "PRIOR TO EVERY USE OF THE NEOPUFF". FURTHERMORE, THE NEOPUFF TECHNICAL MANUAL STATES THE FOLLOWING: "THE INTEGRITY OF THE SYSTEM AND MANOMETER SHOULD BE CHECKED PRIOR TO FIRST USE, ANNUAL AND AFTER SERVICING", "WARNING 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".

    Additional Manufacturer Narrative · 1

    (B)(4). THE RD900AWU NEOPUFF INFANT RESUSCITATOR IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVE THE COMPLAINT DEVICE AND HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN RD900AWU NEOPUFF INFANT RESUSCITATOR DID NOT PASS THE VALVE SYSTEM TEST. THE REQUIRED PRESSURE WAS NOT ACHIEVED WHEN THE GAS SUPPLY WAS SET TO 5 LPM, AS SPECIFIED IN THE PERFORMANCE CHECK PROCEDURE. THIS WAS NOTICED AFTER USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN RD900AWU NEOPUFF INFANT RESUSCITATOR DID NOT PASS THE VALVE SYSTEM TEST. THE REQUIRED PRESSURE WAS NOT ACHIEVED WHEN THE GAS SUPPLY WAS SET TO 5 LPM, AS SPECIFIED IN THE PERFORMANCE CHECK PROCEDURE. THIS WAS NOTICED AFTER USE ON A PATIENT. 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 RD900AWU

    Patients

    Seq Age Sex Outcome Treatment
    1