BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 11683653 · Received April 18, 2021

    Report

    Report Number
    9611451-2021-00439
    Event Type
    Malfunction
    Date Received
    April 18, 2021
    Date of Event
    March 24, 2021
    Report Date
    March 24, 2021
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). METHOD: THE RD900 NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO THE FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTRE IN CALIFORNIA WHERE IT WAS INSPECTED BY A TRAINED F&P SERVICE TECHNICIAN. THE UNIT WAS SERVICED AND PERFORMANCE TESTED. OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE F&P SERVICE TECHNICIAN AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: VISUAL INSPECTION OF THE COMPLAINT RD900 NEOPUFF INFANT RESUSCITATOR REVEALED THAT THE INLET PORT WAS DAMAGED. PERFORMANCE TESTING OF THE COMPLAINT RD900 NEOPUFF INFANT RESUSCITATOR CONFIRMED THAT THE MANOMETER NEEDLE WAS STUCK. THE SUBJECT NEOPUFF WAS REPAIRED AND RETURNED TO THE CUSTOMER AFTER PASSING ALL THE REQUIRED SAFETY AND PERFORMANCE TESTS. CONCLUSION: THE MOST LIKELY CAUSE OF THESE EVENTS 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. IS IT NOTED THAT THE SUBJECT NEOPUFF IS OVER 14 YEARS OLD. 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. 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". 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 REQUIREMENTS AT THE TIME OF PRODUCTION.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN NEW YORK REPORTED THAT A RD900 NEOPUFF INFANT RESUSCITATOR MANOMETER WAS FAULTY AND NOT RESETTING. UPON DEVICE SERVICING AT THE REGIONAL OFFICE IN CALIFORNIA, IT WAS ALSO DISCOVERED THAT THE INLET PORT WAS DAMAGED. THERE WAS NO 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 MANOMETER WAS FAULTY AND NOT RESETTING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581057 NEOPUFF INFANT RESUSCITATOR BTL BTL RD900 060323

    Patients

    Seq Age Sex Outcome Treatment
    1