BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 20400809 · Received October 8, 2024

    Report

    Report Number
    9611451-2024-00716
    Event Type
    Malfunction
    Date Received
    October 8, 2024
    Report Date
    September 11, 2024
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    UDI-DI
    09420012410955
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4: RD900AGU IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA, RD900AEU. THE 510(K) FOR THAT PRODUCT IS K971695 FISHER AND PAYKEL (F&P) HAVE REQUESTED THE RETURN OF THE COMPLAINT RD900 NEOPUFF INFANT RESUSCITATOR FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4: RD900AGU IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA, RD900AEU. THE 510(K) FOR THAT PRODUCT IS K971695 METHOD: THE COMPLAINT RD900 NEOPUFF INFANT RESUSCITATOR WAS RECEIVED AT FISHER & PAKEL HEALTHCARE (F&P) NEW ZEALAND, WHERE IT WAS PERFORMANCE TESTED AND DISASSEMBLED. RESULTS: PERFORMANCE TESTING CONFIRMED THAT THE VALVES WERE NOT TURNING SMOOTHLY. THE DEVICE WAS DISASSEMBLED, AND IT WAS FOUND THAT THERE WAS EXCESSIVE GREASE ON THE VALVE ADJUSTMENT KNOB WHICH PREVENTED SMOOTH MOVEMENT WHILE ROTATING THE KNOB. CONCLUSION: THE REPORTED FAULT WAS DUE TO EXCESSIVE GREASE THAT WAS APPLIED TO THE VALVE DURING THE MANUFACTURING OF THE COMPLAINT DEVICE. THIS GREASE PREVENTED SMOOTH MOVEMENT WHILE ROTATING THE KNOB OF THE VALVE. 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". F&P HEALTHCARE HAS COMPLETED THE FAILURE INVESTIGATION FOR THE REPORTED COMPLAINT. AS A RESULT, AN UPDATE TO GREASE APPLICATION PROCESS WAS PERFORMED TO AVOID THE GREASE CATCHING ON THE HOUSING.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54185 FISHER & PAYKEL HEALTHCARE INFANT RESUSCITATOR FMT FISHER & PAYKEL HEALTHCARE LTD RD900AGU 2102248496 09420012410955

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown