BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 11625401 · Received April 6, 2021

    Report

    Report Number
    9611451-2021-00372
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Report Date
    March 10, 2021
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RD900 NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO THE FISHER & PAYKEL HEALTHCARE (F&P) REGIONAL OFFICE IN (B)(4), WHERE IT WAS INSPECTED BY A TRAINED F&P SERVICE TECHNICIAN. OUR INVESTIGATION IS THUS BASED ON THE INFORMATION PROVIDED BY THE F&P SERVICE TECHNICIAN. RESULTS: PERFORMANCE TESTING OF THE COMPLAINT RD900 NEOPUFF INFANT RESUSCITATOR REVEALED THAT THE MANOMETER WAS FAULTY. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT HOWEVER, THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS PHYSICAL DAMAGE DUE TO IMPACT. 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. IT SHOULD BE NOTED THAT THE SUBJECT DEVICE IS OVER FIFTEEN YEARS OLD. 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 WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT TIME OF PRODUCTION. 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".

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED AN ISSUE WITH THE RD900 NEOPUFF INFANT RESUSCITATOR. UPON DEVICE SERVICING AT THE FISHER & PAYKEL HEALTHCARE (F&P) REGIONAL OFFICE IN (B)(4), IT WAS FOUND THAT THE MANOMETER WAS FAULTY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520339 NEOPUFF INFANT RESUSCITATOR BTL BTL RD900 050323

    Patients

    Seq Age Sex Outcome Treatment
    1