BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 1899253 · Received November 15, 2010

    Report

    Report Number
    9611451-2010-00699
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Report Date
    October 25, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED NEOPUFF FASCIA AND VALVE SYSTEM WERE VISUALLY INSPECTED FOR DAMAGE. RESULTS: THE OUTLET PORT HAD BROKEN OFF OF THE MANIFOLD, CONFIRMING THE REPORTED FAULT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 090819. 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. EACH NEOPUFF IS TESTED DURING PRODUCTION FOR THE ACCURACY OF ITS MANOMETER AND VALVE ASSEMBLY COMPONENTS. 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". NO PATIENT CONSEQUENCE WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE OUTLET PORT ON AN RD900 NEOPUFF INFANT RESUSCITATOR BROKE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE OUTLET PORT ON AN RD900 NEOPUFF INFANT RESUSCITATOR BROKE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOPUFF INFANT RESUSCITATOR INFANT RESUSCITATOR BTL FISHER & PAYKEL HEALTHCARE RD900AEU 090819

    Patients

    Seq Age Sex Outcome Treatment
    1