BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 2012433 · Received March 9, 2011

    Report

    Report Number
    9611451-2011-00144
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Report Date
    February 9, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE NEOPUFF COMPONENTS WERE VISUALLY INSPECTED FOR DAMAGE. RESULTS: THE GAS INLET PORT WAS BROKEN OFF OF THE MANIFOLD. THE COLOR ON THE FRACTURED SECTION IS UNIFORM. THE END CAP ON THE REAR CASE OF THE NEOPUFF WAS DAMAGED. IN ADDITION, IT WAS OBSERVED THAT THE UPPER AND LOWER END CAPS WERE MISSING FROM THE DEVICE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 090124. 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. THE DAMAGE TO THE NEOPUFF CASE AND GAS INLET PORT IS CONSISTENT WITH IMPACT DAMAGE. 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 DEVICE HAS BEEN RECEIVED BY FISHER & PAYKEL HEALTHCARE'S REGIONAL OFFICE AND SERVICE CENTER IN (B)(4). THE COMPONENTS ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE COMPONENTS AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A MEDICAL CENTER IN (B)(6) REPORTED THAT THE GAS OUTLET PORT ON AN RD900 NEOPUFF INFANT RESUSCITATOR WAS DAMAGED.NO PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    A MEDICAL CENTER IN (B)(6) REPORTED THAT THE GAS OUTLET PORT ON AN RD900 NEOPUFF INFANT RESUSCITATOR WAS DAMAGED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LIMITED RD900AEU 090124

    Patients

    Seq Age Sex Outcome Treatment
    1