BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 3951487 · Received July 22, 2014

    Report

    Report Number
    9611451-2014-00645
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Report Date
    June 25, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RD900 INFANT NEOPUFF RESUSCITATOR WAS RETURNED TO OUR SERVICE CENTER IN (B)(6) WHERE IT WAS VISUALLY INSPECTED BY A TRAINED FPH SERVICE ENGINEER. THEREFORE, OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY OUR SERVICE CENTER. RESULTS: VISUAL INSPECTION REVEALED THAT THE GAS OUTLET PORT ON THE RD900 WAS BROKEN. THE UPPER END CAP WAS ALSO FOUND TO BE CRACKED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 120711. 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, VALVE SYSTEM, AND UPPER END CAP 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 DAMAGED. A SERVICE OF THE DEVICE WAS REQUESTED.NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428487 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900 120711

    Patients

    Seq Age Sex Outcome Treatment
    1