BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 11735900 · Received April 27, 2021

    Report

    Report Number
    9611451-2021-00499
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    March 30, 2021
    Report Date
    March 30, 2021
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). METHOD: THE COMPLAINT RD900 NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO THE F&P SERVICE CENTER IN THE US WHERE IT WAS INSPECTED BY A TRAINED F&P SERVICE TECHNICIAN. RESULT: THE F&P SERVICE TECHNICIAN CONFIRMED THAT THE MANOMETER WAS OUT OF SPECIFICATION. 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. IT SHOULD BE NOTED THAT THE SUBJECT NEOPUFF RESUSCITATOR IS ALMOST 20 YEARS OLD. 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. 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". 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 SPECIFICATION AT TIME OF PRODUCTION.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN PENNSYLVANIA REPORTED THAT A RD900 NEOPUFF INFANT RESUSCITATOR VALVE WAS FAULTY. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RD900 NEOPUFF INFANT RESUSCITATOR IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT A RD900 NEOPUFF INFANT RESUSCITATOR VALVE WAS FAULTY. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632078 NEOPUFF INFANT RESUSCITATOR BTL BTL RD900 011101

    Patients

    Seq Age Sex Outcome Treatment
    1