BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 19824027 · Received July 25, 2024

    Report

    Report Number
    9611451-2024-00541
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    June 6, 2024
    Report Date
    June 27, 2024
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    UDI-DI
    09420012429728
    PMA / PMN Number
    K122432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FISHER & PAYKEL (F&P) HEALTHCARE IS CURRENTLY IN THE PROCESS OF FINALIZING THE INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). CORRECTIONS: SECTION D1: BRAND NAME UPDATED TO FISHER & PAYKEL HEALTHCARE. SECTION D2A: COMMON DEVICE NAME UPDATED TO BREATHING CIRCUIT. SECTION D2B: DEVICE PRODUCT CODE UPDATED TO BZE. SECTION D4: MODEL AND CATALOG# UPDATED TO RT380. SECTION G4: PMA/510(K) NUMBER UPDATED TO K122432. SECTION H4: DEVICE MANUFACTURER DATE UPDATED. H11: METHOD: THE SUBJECT MR290V HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN NEW ZEALAND, WHERE IT WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED MULTIPLE CRACKS ON THE BOTTOM OF THE DOME OF THE MR290V HUMIDIFICATION CHAMBER. STRESS WHITENING WAS OBSERVED NEAR THE CRACKED AREAS. ADDITIONALLY, WHITE RESIDUE WAS OBSERVED INSIDE OF THE CHAMBER AND ON THE PRIMARY FLOAT. CONCLUSION: THE CAUSE OF THE REPORTED WATER LEAK IS DUE TO THE CRACKS AT THE BOTTOM OF THE CHAMBER DOME. THE STRESS WHITENING INDICATES THAT THE CHAMBER WAS MOST LIKELY EXPOSED TO AN EXTERNAL MECHANICAL FORCE. WE ARE UNABLE TO CONFIRM THE SOURCE OF THE EXTERNAL MECHANICAL FORCE. EVERY MR290 CHAMBER IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DUE TO CRACKS AND OTHER CAUSES. ANY CHAMBER WHICH FAILS THIS TEST IS REJECTED. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. NO CRACKS IN THE CHAMBER DOME ARE ACCEPTABLE. ANY CHAMBER THAT FAILS THIS INSPECTION IS REJECTED. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT380 BREATHING CIRCUIT STATE THE FOLLOWING: "DO NOT SOAK, WASH, STERILIZE, OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS." "DO NOT USE THE CHAMBER IF THE SEALS ARE NOT INTACT WHEN RECEIVED, OR IF IT HAS BEEN DROPPED." "VISUALLY INSPECT BREATHING SETS FOR DAMAGE (E.G. A CRUSHED TUBE OR CRACKED CONNECTOR) BEFORE USE AND REPLACE IF DAMAGED." "ENSURE APPROPRIATE VENTILATOR AND FLOW SOURCE ALARMS ARE SET BEFORE CONNECTING BREATHING SET TO PATIENT."

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT A MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH A RT380 ADULT BREATHING CIRCUIT WAS FOUND LEAKING WATER DURING PATIENT USE. THERE WAS NO REPORTED PATIENT HARM.

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT A MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH A RT380 ADULT BREATHING CIRCUIT WAS FOUND LEAKING WATER DURING PATIENT USE. THERE WAS NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354231 FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE LTD RT380 2102979653 09420012429728

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown