BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 6334803 · Received February 15, 2017

    Report

    Report Number
    9611451-2017-00097
    Event Type
    Malfunction
    Date Received
    February 15, 2017
    Date of Event
    January 17, 2017
    Report Date
    January 17, 2017
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT FRONT FASCIA AND VALVE SYSTEM OF THE RD900 NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION AND WAS VISUALLY INSPECTED. RESULT: VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THE MANOMETER PVC TUBING WAS DETACHED FROM THE MANIFOLD. CONCLUSION: IT IS POSSIBLE THAT THE TUBE MAY HAVE BEEN PULLED OR MANIPULATED WITH EXCESSIVE FORCE TO CAUSE THE REPORTED DAMAGE. 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".

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT FRONT FASCIA OF THE RD900 NEOPUFF INFANT RESUSCITATOR WAS RECENTLY RECEIVED AT FISHER & PAYKEL HEALTHCARE IN (B)(6) FOR EVALUATION, TO DETERMINE IF IT HAD A MALFUNCTION WHICH MIGHT HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WE WILL SUBMIT A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED THAT THE MANOMETER TUBING CONNECTION ON THE FRONT FASCIA OF AN RD900 NEOPUFF INFANT RESUSCITATOR WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED THAT THE MANOMETER TUBING CONNECTION ON THE FRONT FASCIA OF AN RD900 NEOPUFF INFANT RESUSCITATOR WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116719 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900 2100065171

    Patients

    Seq Age Sex Outcome Treatment
    1