BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF FASCIA & VALVE ASSEMBLY

    MDR report key: 12064432 · Received June 24, 2021

    Report

    Report Number
    9611451-2021-00733
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Report Date
    May 28, 2021
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). METHOD: THE COMPLAINT (B)(4) NEOPUFF FASCIA & VALVE ASSEMBLY WAS NOT RETURNED TO THE FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: VISUAL INSPECTION OF THE PROVIDED PHOTOGRAPH OF THE COMPLAINT (B)(4) NEOPUFF INFANT RESUSCITATOR CONFIRMED THAT THE TUBING HAD DETACHED. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. 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 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. 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. 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 THE PRESSURE SETTINGS "PRIOR TO EVERY USE OF THE NEOPUFF".

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN THE USA REPORTED THAT ONE OF THE TUBING ASSEMBLY OF THE (B)(4) NEOPUFF FASCIA & VALVE ASSEMBLY WAS DETACHING. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT 043042347 NEOPUFF FASCIA & VALVE ASSEMBLY IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN THE USA REPORTED THAT ONE OF THE TUBING ASSEMBLY OF THE 043042347 NEOPUFF FASCIA & VALVE ASSEMBLY WAS DETACHING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961145 NEOPUFF FASCIA & VALVE ASSEMBLY BTL BTL 043042347 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1