BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 3607215 · Received February 4, 2014

    Report

    Report Number
    9611451-2014-00098
    Event Type
    Malfunction
    Date Received
    February 4, 2014
    Date of Event
    January 9, 2014
    Report Date
    January 9, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RD900AEU NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO FPH SERVICE CENTRE IN IRVINE, CALIFORNIA, WHERE IT WAS INSPECTED BY A TRAINED FPH SERVICE ENGINEER. OUR INVESTIGATION IS ACCORDINGLY BASED ON THE SERVICE REPORT PROVIDED BY FPH SERVICE CENTRE AND RESULTS OF PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS. RESULTS: THE SERVICE REPORT STATED THAT THE GAS INLET PORT AND THE LOWER END CAP OF THE SUBJECT NEOPUFF UNIT WERE CRACKED. THE PLUG SETS WERE ALSO MISSING. A LOT CHECK REVEALED THAT WE RECEIVED TWO OTHER COMPLAINTS RELATED TO BROKEN OR DAMAGED PORT FOR LOT NUMBER 070911. CONCLUSION: THE NEOPUFF IS A PORTABLE, REUSABLE DEVICE USED TO ASSIST IN THE DELIVERY OF RESPIRATORY BREATHS TO INFANT 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 STATES THE FOLLOWING: "DROPPING THE NEOPUFF 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." ALL NEOPUFF UNITS ARE VISUALLY INSPECTED AND PERFORMANCE TESTED BEFORE LEAVING THE PRODUCTION LINE AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE NEOPUFF UNIT WAS DAMAGED AFTER IT WAS RELEASED FOR DISTRIBUTION. THE FAULTY PARTS AND THE MISSING PLUG SETS WERE REPLACED, AND THE SUBJECT NEOPUFF WAS RETURNED TO THE HOSPITAL AFTER PASSING THE PERFORMANCE CHECK SPECIFIED IN THE NEOPUFF TECHNICAL MANUAL.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RD900AEU NEOPUFF INFANT RESUSCITATOR HAD PHYSICAL DAMAGE. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72429 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LIMITED RD900AEU

    Patients

    Seq Age Sex Outcome Treatment
    1