BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 2844196 · Received November 25, 2012

    Report

    Report Number
    9611451-2012-00855
    Event Type
    Malfunction
    Date Received
    November 25, 2012
    Report Date
    October 30, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RD900 NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) SERVICE CENTRE IN (B)(4) WHERE IT WAS INSPECTED BY A TRAINED FPH TECHNICIAN. RESULTS: VISUAL INSPECTION OF THE NEOPUFF REVEALED THAT THE GAS OUTLET PORT WAS BROKEN. CONCLUSION: THE NEOPUFF IS A PORTABLE, REUSABLE DEVICE USED TO ASSIST IN THE DELIVERY OF RESPIRATORY BREATHS TO INFANT 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. IT IS MOST LIKELY THAT THE PHYSICAL DAMAGE TO THE GAS OUTLET PORT WERE CAUSED BY SOME SORT OF IMPACT. IT SHOULD ALSO BE NOTED THAT THE DEVICE IS 13 YEARS OLD. 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." THE NEOPUFF WAS FITTED WITH A NEW FRONT PANEL AND VALVE ASSEMBLY, GIVEN A FULL PERFORMANCE CHECK AND RETURNED TO THE CUSTOMER TO BE PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE GAS OUTLET ON AN RD900 INFANT RESUSCITATOR WAS BROKEN AND REQUESTED A REPAIR OF THE DEVICE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1