BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 7062286 · Received November 27, 2017

    Report

    Report Number
    9611451-2017-01111
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Report Date
    November 1, 2017
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    UDI-DI
    09420012410931
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RD900 NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO THE FPH SERVICE CENTER IN (B)(6) WHERE IT WAS INSPECTED BY A TRAINED FPH SERVICE TECHNICIAN. OUR INVESTIGATION IS BASED ON THE SERVICE REPORT PROVIDED BY THE FPH SERVICE TECHNICIAN. RESULTS: THE FPH SERVICE ENGINEER REPORTED THAT THE GAS OUTLET PORT AND CASE ENCLOSURE OF THE NEOPUFF WERE DAMAGED. 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 DAMAGE, FOR INSTANCE WHEN ACCIDENTALLY DROPPED OR SUBJECTED TO CONSIDERABLE EXTERNAL FORCE. THE PHYSICAL DAMAGE OBSERVED WAS MOST LIKELY DUE TO IMPACT TO THE SUBJECT NEOPUFF UNIT. 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." EACH NEOPUFF UNIT IS ASSEMBLED AND 100% TESTED IN THE PRODUCTION LINE TO VERIFY THAT EACH UNIT CONFORMS TO CRITICAL PRODUCT SPECIFICATIONS. ANY UNIT THAT FAILS IS REJECTED. THE SUBJECT NEOPUFF UNIT WAS REPAIRED AND RETURNED TO THE HOSPITAL AFTER PASSING THE PERFORMANCE TESTS SPECIFIED ON THE NEOPUFF TECHNICAL MANUAL.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RD900 NEOPUFF INFANT RESUSCITATOR HAD A BROKEN GAS OUTLET PORT. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837487 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LIMITED RD900 2100052350 09420012410931

    Patients

    Seq Age Sex Outcome Treatment
    1