BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 4389813 · Received January 6, 2015

    Report

    Report Number
    9611451-2015-00009
    Event Type
    Malfunction
    Date Received
    January 6, 2015
    Date of Event
    December 8, 2014
    Report Date
    December 8, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT NEOPUFF WAS RECEIVED AT OUR REGIONAL OFFICE IN THE US, WHERE IT WAS INSPECTED BY A TRAINED FISHER & PAYKEL HEALTHCARE SERVICE ENGINEER. RESULTS: THE SERVICE REPORT STATED THAT THE TUBE FROM THE MANIFOLD HAD DETACHED FROM THE MANOMETER. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS FOR LOT 140604. CONCLUSION: THE NEOPUFF IS ASSEMBLED AND 100% TESTED ON THE PRODUCTION LINE TO VERIFY THAT EACH NEOPUFF PRODUCT CONFORMS TO CRITICAL PRODUCT SPECIFICATIONS. THE NEOPUFF TECHNICAL MANUAL WARNS AGAINST DROPPING THE NEOPUFF OR SUBJECTING IT TO IMPACT DAMAGE WHICH MAY CAUSE THE UNIT TO OPERATE INCORRECTLY. IF THE NEOPUFF IS SUSPECTED TO HAVE BEEN DAMAGED, THE MANOMETER AND VALVE SYSTEM SHOULD BE PERFORMANCE TESTED. 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 TUBE WAS CONNECTED TO THE MANIFOLD AND TESTED BASED ON THE NEOPUFF TECHNICAL MANUAL. THE DEVICE WAS RETURNED TO THE CUSTOMER AFTER PASSING THE PERFORMANCE TEST.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT AN RD900AEU NEOPUFF INFANT RESUSCITATOR WOULD NOT WORK CORRECTLY. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5448 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LIMITED RD900 140604

    Patients

    Seq Age Sex Outcome Treatment
    1