BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 3041950 · Received April 9, 2013

    Report

    Report Number
    9611451-2013-00247
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION ABOUT THE REPORTED FAULT. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RD900AEU NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO OUR FISHER & PAYKEL HEALTHCARE (FPH) SERVICE CENTRE IN IRVINE, CALIFORNIA, WHERE IT WAS VISUALLY INSPECTED AND PERFORMANCE TESTED BY A TRAINED FPH SERVICE ENGINEER. OUR ANALYSIS IS ACCORDINGLY BASED ON THE SERVICE REPORT AND PHOTOGRAPHS PROVIDED BY THE FPH SERVICE ENGINEER. RESULTS: NO CRACKS WERE OBSERVED ON THE OUTER CASING OF THE RETURNED NEOPUFF; HOWEVER, THE PLUG SETS WERE MISSING. THE VALVE SYSTEM AND THE MANOMETER FAILED THE PERFORMANCE CHECKS PRESCRIBED ON THE NEOPUFF TECHNICAL MANUAL. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 060902. CONCLUSION: THE PROBLEM WITH THE INSPIRATORY PRESSURE REPORTED BY THE BIOMED WAS DUE TO FAULTY MANOMETER AND VALVE SYSTEM. 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. IN ADDITION 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." THE COMPLAINT NEOPUFF DEVICE WAS RETURNED TO THE HOSPITAL UNREPAIRED, AS PER BIOMED'S REQUEST. THE FPH SERVICE ENGINEER INFORMED THE BIOMED THAT THE SUBJECT NEOPUFF SHOULD NOT BE USED UNTIL THE RECOMMENDED REPAIRS ARE CONDUCTED.

    Description of Event or Problem · 1

    A MEDICAL CENTRE IN BOISE, IDAHO REPORTED THAT WHEN THE INSPIRATORY PRESSURE ON AN RD900AEU NEOPUFF INFANT RESUSCITATOR WAS INCREASED HIGHER THAN 30CMH2O, THE MANOMETER GAUGE DROPPED DRASTICALLY TO 10CMH2O. THIS WAS NOTICED AFTER USE ON A PATIENT. IT WAS ALSO REPORTED THAT THE CIRCUIT WAS CLOSED WHEN THE REPORTED FAULT WAS OBSERVED.

    Description of Event or Problem · 1

    A MEDICAL CENTRE IN (B)(6) REPORTED THAT WHEN THE INSPIRATORY PRESSURE ON AN RD900AEU NEOPUFF INFANT RESUSCITATOR WAS INCREASED HIGHER THAN 30CMH2O, THE MANOMETER GAUGE DROPPED DRASTICALLY TO 10CMH2O. THIS WAS NOTICED AFTER USE ON A PATIENT. IT WAS ALSO REPORTED THAT THE CIRCUIT WAS CLOSED WHEN THE REPORTED FAULT WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145718 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LIMITED RD900AEU

    Patients

    Seq Age Sex Outcome Treatment
    1