BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 6153645 · Received December 7, 2016

    Report

    Report Number
    9611451-2016-00839
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Report Date
    September 9, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT NEOPUFF DEVICE WAS RECEIVED AT THE FISHER & PAYKEL HEALTHCARE (FPH) SERVICE CENTER IN THE U.S. AND WAS INSPECTED BY A TRAINED FPH SERVICE ENGINEER. THE NEOPUFF HAS BEEN REPAIRED AND THE MANOMETER HAS BEEN REPLACED AT THE US SERVICE CENTER, AND THE NEOPUFF WAS RETURNED TO THE CUSTOMER AFTER PASSING THE PERFORMANCE CHECKS SPECIFIED IN THE NEOPUFF TECHNICAL MANUAL. THE MANOMETER OF THE SUBJECT NEOPUFF WAS RETURNED TO FPH IN (B)(4) FOR FURTHER EVALUATION. THE RETURNED MANOMETER WAS FITTED INTO A KNOWN GOOD VALVE SYSTEM AND PERFORMANCE TESTED BASED ON THE NEOPUFF TECHNICAL MANUAL. OUR INVESTIGATION IS BASED ON THE SERVICE REPORT AND PHOTOGRAPHS PROVIDED BY THE FPH SERVICE ENGINEER, AND THE RESULTS OF THE INVESTIGATION AT FPH (B)(4). RESULTS: EVALUATION OF THE PROVIDED SERVICE REPORT REVEALED THAT THE SUBJECT NEOPUFF FAILED THE MANOMETER CHECK AND THE GAS INLET PORT WAS DAMAGED. VISUAL INSPECTION OF THE PROVIDED PHOTOGRAPHS CONFIRMED THAT THE GAS INLET PORT WAS DAMAGED. THE MANOMETER OF THE COMPLAINT NEOPUFF UNIT WAS PERFORMANCE TESTED AT FPH (B)(4) AND IT WAS CONFIRMED THAT THE MANOMETER WAS OUT OF SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS NATURE FOR LOT 070904. 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 9 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 U.S. SERVICE CENTER AND RETURNED TO THE CUSTOMER AFTER PASSING PERFORMANCE CHECKS SPECIFIED IN THE NEOPUFF TECHNICAL MANUAL.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN THE U.S. REPORTED BY PHONE THAT THE RD900 NEOPUFF INFANT RESUSCITATOR'S PRESSURE READING WAS OUT OF SPECIFICATION. A SERVICE WAS REQUESTED. DURING SERVICING, IT WAS OBSERVED AND CONFIRMED THAT THE MANOMETER WAS OUT OF SPECIFICATION. IT WAS ALSO OBSERVED THAT THE GAS INLET PORT OF THE SUBJECT NEOPUFF WAS DAMAGED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803013 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900

    Patients

    Seq Age Sex Outcome Treatment
    1