BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 6029002 · Received October 13, 2016

    Report

    Report Number
    9611451-2016-00660
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Report Date
    September 15, 2016
    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 COMPLAINT RD900 NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO THE FISHER & PAYKEL HEALTHCARE (FPH) SERVICE CENTER IN (B)(4). THE SUBJECT NEOPUFF WAS VISUALLY INSPECTED BY QUALIFIED FPH SERVICE ENGINEER. OUR ANALYSIS IS ACCORDINGLY BASED ON THE SERVICE REPORT AND PHOTOGRAPH PROVIDED BY THE FPH SERVICE CENTER. RESULTS: VISUAL INSPECTION OF THE SUPPLIED PHOTOGRAPH REVEALED A DAMAGED GAS INLET PORT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 140606. CONCLUSION: IT IS MOST LIKELY THAT THE PHYSICAL DAMAGE TO THE GAS INLET PORT WAS CAUSED BY SOME SORT OF IMPACT. 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 NEOPUFF UNITS ARE VISUALLY INSPECTED AND PERFORMANCE TESTED BEFORE LEAVING THE PRODUCTION LINE AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE SUBJECT NEOPUFF UNIT WAS DAMAGED AFTER IT WAS RELEASED FOR DISTRIBUTION. 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". THE SUBJECT NEOPUFF HAS BEEN REPAIRED AT THE FPH SERVICE CENTER, AND WAS RETURNED TO HOSPITAL SERVICE AFTER PASSING THE PERFORMANCE CHECK SPECIFIED IN THE NEOPUFF TECHNICAL MANUAL.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A BIOMEDICAL ENGINEER THAT THE INLET PORT OF AN RD900 NEOPUFF INFANT RESUSCITATOR HAD BECOME MISSHAPEN. A SERVICE OF THE DEVICE WAS ALSO REQUESTED. THIS WAS DISCOVERED BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680092 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900 140606

    Patients

    Seq Age Sex Outcome Treatment
    1