BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 2598156 · Received June 5, 2012

    Report

    Report Number
    9611451-2012-00362
    Event Type
    Malfunction
    Date Received
    June 5, 2012
    Date of Event
    May 10, 2012
    Report Date
    May 10, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MANOMETER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) IN (B)(4) FOR INSPECTION. IT WAS VISUALLY INSPECTED AND PERFORMANCE TESTED FOR THE REPORTED FAULT. RESULTS: VISUAL INSPECTION REVEALED THAT THE MANOMETER PORT WAS SLIGHTLY BENT, CAUSING THE DIAL GAUGE SURFACE TO RAISE AND IMPEDE THE MOVEMENT OF THE MANOMETER NEEDLE INTERMITTENTLY. DURING THE PERFORMANCE TEST, IT WAS OBSERVED THAT THE MANOMETER NEEDLE WAS STICKING ON THE DIAL GAUGE INTERMITTENTLY. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120201. 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. ALL MANOMETERS OF THE NEOPUFF UNITS ARE VISUALLY INSPECTED AND PERFORMANCE TESTED PRIOR TO LEAVING THE PRODUCTION LINE, AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE SUBJECT MANOMETER WAS DAMAGED POST PRODUCTION, MOST LIKELY DURING TRANSPORT. 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".

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MANOMETER OF THE RD900AEU NEOPUFF INFANT RESUSCITATOR UNIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE MANOMETER NEEDLE OF AN RD900AEU NEOPUFF INFANT RESUSCITATOR WAS STUCK AT 50CMH2O DURING PERFORMANCE CHECK. THIS WAS NOTICED PRIOR TO PATIENT USE. THE DEFECTIVE MANOMETER WAS A SPARE PART OF THE NEOPUFF UNIT.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE MANOMETER NEEDLE OF AN (B)(4) NEOPUFF INFANT RESUSCITATOR WAS STUCK AT 50 CMH2O DURING PERFORMANCE CHECK. THIS WAS NOTICED PRIOR TO PATIENT USE. THE DEFECTIVE MANOMETER WAS A SPARE PART OF THE NEOPUFF UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LIMITED RD900AEU 120203 (FOR SPARE MANOMETER)

    Patients

    Seq Age Sex Outcome Treatment
    1