BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 12097469 · Received June 30, 2021

    Report

    Report Number
    9611451-2021-00748
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Report Date
    June 1, 2021
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RD900 NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO THE FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTRE IN (B)(6) 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: INSPECTION OF THE SUBJECT NEOPUFF INFANT RESUSCITATOR REVEALED THAT THE MANOMETER WAS OUT OF SPECIFICATION. THE SUBJECT NEOPUFF WAS REPAIRED AND RETURNED TO THE CUSTOMER AFTER PASSING ALL THE REQUIRED SAFETY AND PERFORMANCE TESTS. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT CAUSED THE REPORTED FAULT. 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 · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE MANOMETER OF A RD900 NEOPUFF INFANT RESUSCITATOR WAS FAULTY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989801 NEOPUFF INFANT RESUSCITATOR BTL BTL RD900

    Patients

    Seq Age Sex Outcome Treatment
    1