BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 1930893 · Received December 16, 2010

    Report

    Report Number
    9611451-2010-00748
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Report Date
    November 18, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. IT HAS BEEN VISUALLY INSPECTED BY A FISHER & PAYKEL HEALTHCARE SERVICE ENGINEER AT OUR REGIONAL OFFICE IN (B)(4). THE COMPLAINT DEVICE WAS IN POOR CONDITION UPON ARRIVAL AT OUR OFFICE IN (B)(4). RESULTS: THE VISUAL INSPECTION REVEALED MANY CRACKS ON THE FRONT FASCIA OF THE COMPLAINT DEVICE AND THE INSPIRATORY PRESSURE CONTROL VALVE WAS STUCK. CONCLUSION: BASED ON THE CRACKS REVEALED FROM THE VISUAL INSPECTION, IT IS LIKELY THAT THE NEOPUFF WAS IMPACTED, CAUSING THE INSPIRATORY PRESSURE CONTROL VALVE TO BE STUCK. 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 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 COMPLAINT DEVICE HAS BEEN REPAIRED AND RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT THE INSPIRATORY PRESSURE CONTROL VALVE OF AN RD900 NEOPUFF INFANT RESUSCITATOR "IS STUCK." 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 RD900AEU

    Patients

    Seq Age Sex Outcome Treatment
    1