BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 2973177 · Received February 21, 2013

    Report

    Report Number
    9611451-2013-00138
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    January 25, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 CENTER IN (B)(4) FOR REPAIR. THE DEVICE WAS VISUALLY INSPECTED BY A TRAINED FPH SERVICE PERSONNEL. RESULTS: VISUAL INSPECTION REVEALED THAT THE GAS INLET AND OUTLET PORTS WERE PHYSICALLY BROKEN. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT NUMBER 120126. CONCLUSION: THE DAMAGE TO THE GAS INLET AND OUTLET PORTS IS MOST LIKELY TO HAVE BEEN CAUSED BY PHYSICAL DAMAGE DUE TO SIGNIFICANT IMPACT. 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 NEOPUFF TECHNICAL MANUAL ADVISES THAT "THE INTEGRITY OF THE SYSTEM AND MANOMETER SHOULD BE CHECKED PRIOR TO FIRST USE, ANNUALLY AND AFTER SERVICING" BY A QUALIFIED PERSONNEL OR AN AUTHORIZED FISHER & PAYKEL HEALTHCARE REPRESENTATIVE USING THE TESTS DESCRIBED IN THE MANUAL. THE COMPLAINT NEOPUFF DEVICE IS CURRENTLY AWAITING PARTS FOR REPAIR. FOLLOWING THE REPAIR, THE NEOPUFF DEVICE WILL BE PERFORMANCE TESTED TO OUR SPECIFICATION PRIOR TO BEING RETURNED TO THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RD900 NEOPUFF INFANT RESUSCITATOR WAS RECENTLY RETURNED TO FISHER & PAYKEL HEALTHCARE SERVICE CENTER IN (B)(4) FOR REPAIR. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF THE REPORT AND OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE GAS PORT OF AN RD900 INFANT RESUSCITATOR WAS BROKEN. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE GAS PORT OF AN RD900 INFANT RESUSCITATOR WAS BROKEN. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75986 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900

    Patients

    Seq Age Sex Outcome Treatment
    1