BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 2990503 · Received March 5, 2013

    Report

    Report Number
    9611451-2013-00160
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Report Date
    February 4, 2013
    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 NEOPUFF WAS RETURNED TO OUR REGIONAL OFFICE IN (B)(4). THE NEOPUFF WAS INSPECTED BY A TRAINED FISHER & PAYKEL HEALTHCARE SERVICE ENGINEER. OUR INVESTIGATION IS BASED ON THE PHOTOGRAPHS AND SERVICE REPORT PROVIDED BY THE AUSTRALIAN OFFICE. RESULTS: VISUAL INSPECTION OF THE PHOTOGRAPHS REVEALED THAT THE RESERVOIR WAS CRACKED IN THE VICINITY OF BOTH BLUE PLUGS AND THAT THE HOSE CONNECTOR WAS BROKEN. A LOT CHECK REVEALED ONE OTHER COMPLAINT FOR A FAULTY MANOMETER FOR THE LOT NUMBER PROVIDED. 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. IT MUST BE NOTED THAT THIS NEOPUFF WAS MANUFACTURED IN 1995 AND HAD THUS BEEN IN SERVICE FOR AROUND 17-18 YEARS. 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". IN ADDITION THE NEOPUFF USER INSTRUCTIONS STATE THAT THE USER SHOULD "CHECK MANOMETER READS ZERO WITH NO GAS FLOW" AND CHECK THE PRESSURE SETTINGS "PRIOR TO EVERY USE OF THE NEOPUFF". THE (B)(4) SERVICE CENTRE SCRAPPED THE NEOPUFF AS IT IS OBSOLETE AND PROVIDED THE CUSTOMER WITH THE CURRENT MODEL OF AN RD900 NEOPUFF RESUSCITATOR.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE GAS RESERVOIR OF A NEOPUFF INFANT RESUSCITATOR WAS CRACKED AND THAT THE HOSE CONNECTOR WAS BROKEN. THIS WAS FOUND BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93977 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD1000

    Patients

    Seq Age Sex Outcome Treatment
    1