BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 6982667 · Received October 26, 2017

    Report

    Report Number
    9611451-2017-00997
    Event Type
    Malfunction
    Date Received
    October 26, 2017
    Date of Event
    September 29, 2017
    Report Date
    September 29, 2017
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RD900 FPH NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO OUR REGIONAL OFFICE IN THE (B)(4), WHERE IT WAS INSPECTED BY A FPH TRAINED TECHNICIAN. OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE REGIONAL OFFICE. RESULTS: VISUAL INSPECTION OF THE SUBJECT NEOPUFF REVEALED THAT THE TUBE HAD DETACHED FROM THE MANOMETER INLET PORT. CONCLUSION: THE NEOPUFF IS ASSEMBLED AND 100% TESTED ON THE PRODUCTION LINE TO VERIFY THAT EACH NEOPUFF PRODUCT CONFORMS TO CRITICAL PRODUCT SPECIFICATIONS. ALL NEOPUFFS ARE VISUALLY INSPECTED AND PERFORMANCE TESTED PRIOR TO LEAVING THE PRODUCTION LINE, AND THOSE THAT FAIL ARE REJECTED. 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 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 SERVICE CENTRE REFITTED THE MANOMETER TUBE AND THE DEVICE WAS RETURNED TO THE CUSTOMER AFTER PASSING THE REQUIRED SAFETY AND PERFORMANCE CHECKS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT THERE WAS NO PRESSURE READING FROM THE GAUGE ON A NEOPUFF INFANT RESUSCITATOR. SERVICE WAS REQUESTED FOR THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759304 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900 140925

    Patients

    Seq Age Sex Outcome Treatment
    1