BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 3346015 · Received September 12, 2013

    Report

    Report Number
    9611451-2013-00689
    Event Type
    Malfunction
    Date Received
    September 12, 2013
    Report Date
    August 14, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RD900 NEOPUFF DEVICE WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4). THE DEVICE WAS PERFORMANCE TESTED AND THE MANOMETER WAS DISMANTLED FOR INTERNAL INSPECTION. RESULTS: NO DAMAGE WAS FOUND ON THE EXTERIOR OF THE COMPLAINT NEOPUFF DEVICE. NO FAULT WAS FOUND WITH THE VALVE ASSEMBLY SYSTEM OF THE COMPLAINT NEOPUFF DEVICE. DURING THE PERFORMANCE TEST, THE MANOMETER WAS NOT ABLE TO INDICATE PRESSURE HIGHER THAN 38 CMH2O. INTERNAL INSPECTION OF THE MANOMETER REVEALED THAT AN OBSTRUCTION WAS FOUND IN ONE OF THE GEARS OF THE MANOMETER. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS TYPE FOR LOT NUMBER 130307. CONCLUSION: THE OBSTRUCTION IN THE MANOMETER'S INTERNAL MECHANISM WAS IDENTIFIED AS THE CAUSE OF THE MANOMETER FAILURE TO INDICATE PRESSURE HIGHER THAN 38 CMH2O. WE WERE UNABLE TO IDENTIFY THE CAUSE OF THE OBSTRUCTION IN THE MANOMETER. ALL MANOMETERS OF THE NEOPUFF UNITS ARE VISUALLY INSPECTED AND PERFORMANCE TESTED PRIOR TO LEAVING THE PRODUCTION LINE, AND THOSE THAT FAIL ARE REJECTED. A REVIEW OF OUR DEVICE HISTORY RECORD REVEALED THAT THE COMPLAINT DEVICE PASSED THE PRODUCTION TEST DURING THE TIME OF MANUFACTURE. 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). PLEASE DISREGARD THIS REPORT (# 9611451-2013-00689) AS THE CORRECT REPORT FOR THIS COMPLAINT HAS ALREADY BEEN SUBMITTED UNDER MFR REPORT# 9611451-2013-00670. WE APOLOGIZE FOR ANY INCONVENIENCE CAUSED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE MAXIMUM PRESSURE OF AN RD900 INFANT RESUSCITATOR COULD NOT BE ADJUSTED. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE MAXIMUM PRESSURE OF AN RD900 INFANT RESUSCITATOR COULD NOT BE ADJUSTED. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458701 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900

    Patients

    Seq Age Sex Outcome Treatment
    1