BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 6150196 · Received December 6, 2016

    Report

    Report Number
    9611451-2016-00835
    Event Type
    Malfunction
    Date Received
    December 6, 2016
    Report Date
    November 10, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: ONLY THE MANOMETER OF THE COMPLAINT RD900 NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. THE SUBJECT MANOMETER WAS FITTED INTO A KNOWN GOOD VALVE SYSTEM AND TESTED ACCORDING TO THE NEOPUFF TECHNICAL MANUAL. RESULTS: PERFORMANCE TESTING REVEALED THAT THE MANOMETER WAS OUT OF SPECIFICATION. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT 050623. 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. 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. WE NOTE THAT THE COMPLAINT NEOPUFF IS OVER 10 YEARS OLD. 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 COMPLAINT NEOPUFF WAS REPAIRED AT OUR US SERVICE CENTER AND RETURNED TO THE CUSTOMER AFTER PASSING PERFORMANCE CHECKS SPECIFIED IN THE NEOPUFF TECHNICAL MANUAL.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RD900 NEOPUFF INFANT RESUSCITATOR REQUIRED CALIBRATION. A SERVICE WAS REQUESTED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798065 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900 050623

    Patients

    Seq Age Sex Outcome Treatment
    1