BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 3867725 · Received June 12, 2014

    Report

    Report Number
    9611451-2014-00501
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Report Date
    May 13, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RD900 NEOPUFF RESUSCITATOR WAS RETURNED TO OUR SERVICE CENTER IN (B)(4), WHERE IT WAS INSPECTED BY A TRAINED SERVICE ENGINEER. THE FRONT FASCIA AND VALVE SYSTEM WERE RETURNED TO FISHER & PAYKEL HEATLHCARE IN (B)(4) FOR EVALUATION. THE RETURNED FASCIA WAS VISUALLY INSPECTED FOR THE REPORTED DAMAGE. RESULTS: VISUAL INSPECTION REVEALED THAT THE GAS OUTLET PORT WAS CRACKED. NO OTHER DAMAGE WAS NOTED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 120917. 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 DROPPED OR SUBJECTED TO CONSIDERABLE EXTERNAL FORCE. THE NEOPUFF TECHNICAL MANUAL STATES THE FOLLOWING: "DROPPING THE NEOPUFF 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." ALL NEOPUFF UNITS ARE VISUALLY INSPECTED AND PERFORMANCE TESTED BEFORE LEAVING THE PRODUCTION LINE AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE DAMAGE OCCURRED AFTER THE SUBJECT NEOPUFF UNIT WAS RELEASED FOR DISTRIBUTION. THE RETURNED NEOPUFF DEVICE WAS FITTED WITH A NEW FASCIA AND VALVE SYSTEM AND WAS RETURNED TO THE CUSTOMER AFTER PASSING THE SAFETY AND PERFORMANCE CHECKS AS PER THE NEOPUFF TECHNICAL MANUAL.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6), REPORTED THAT THE GAS OUTLET PORT OF AN RD900 NEOPUFF INFANT RESUSCITATOR WAS BROKEN. A SERVICE OF THE DEVICE WAS REQUESTED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6), REPORTED THAT THE GAS OUTLET PORT OF AN RD900 NEOPUFF INFANT RESUSCITATOR WAS BROKEN. A SERVICE OF THE DEVICE WAS REQUESTED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347041 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900 120917

    Patients

    Seq Age Sex Outcome Treatment
    1