BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 2011226 · Received March 8, 2011

    Report

    Report Number
    9611451-2011-00141
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Report Date
    February 7, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED FASCIA AND VALVE SYSTEM OF THE COMPLAINT DEVICE WAS VISUALLY INSPECTED AND PERFORMANCE TESTED. RESULTS: THE VISUAL INSPECTION REVEALED THAT THE PLASTIC COVER OF THE MANOMETER'S ADJUSTMENT SCREW WAS MISSING. CRACKS ON THE LEFT REAR OF THE UPPER END CAP WERE OBSERVED. THE RUBBER FOOT ON THE LOWER END CAP AND COVERS FOR THE 8 SCREWS WERE MISSING. THE COMPLAINT MANOMETER WAS FITTED INTO A KNOWN GOOD VALVE SYSTEM AND PEFORMANCE TESTED. THE ACTUAL PRESSURE DELIVERED WAS FOUND TO BE LOWER THAN THAT INDICATED ON THE MANOMETER. A KNOWN GOOD MANOMETER WAS FITTED WITH THE COMPLAINT VALVE SYSTEM AND PEFORMANCE TESTED. THE VALVE SYSTEM AND THE MAXIMUM PRESSURE RELIEF VALVE ADJUSTMENT KNOB WAS TESTED AND FOUND TO BE OPERATING CORRECTLY. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. 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 STATES THE FOLLOWING: "DROPPING THE NEOPUFF / PERIVENT 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." 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".

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE HAS RECENTLY BEEN RECEIVED AT OUR REGIONAL OFFICE IN THE USA. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE MAXIMUM PRESSURE RELIEF KNOB OF AN RD900 NEOPUFF INFANT RESUSCITATOR "CANNOT BE ADJUSTED TO ITS LOWEST POINT". NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE MAXIMUM PRESSURE RELIEF KNOB OF AN RD900 NEOPUFF INFANT RESUSCITATOR "CANNOT BE ADJUSTED TO ITS LOWEST POINT". 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 LTD RD900 060217

    Patients

    Seq Age Sex Outcome Treatment
    1