BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 19824066 · Received July 25, 2024

    Report

    Report Number
    9611451-2024-00542
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    June 27, 2024
    Report Date
    June 28, 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
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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: PRODUCT CODE UPDATED TO BZE SECTION D4: MODEL AND CATALOG # UPDATED TO RT380 SECTION G4: PMA/510(K) NUMBER UPDATED METHOD: THE SUBJECT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS NOT RETURNED TO F&P HEALTHCARE. OUR INVESTIGATION IS THEREFORE BASED ON THE INFORMATION AND PHOTOGRAPHS PROVIDED BY THE HEALTHCARE FACILITY AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: REVIEW OF THE PHOTOGRAPHS CONFIRMED A CRACK ALONG THE BASE OF THE CHAMBER. CONCLUSION: WITHOUT THE RETURN OF THE SUBJECT DEVICE, WE ARE NOT ABLE TO DETERMINE THE CAUSE OF THE CRACK. 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 MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER STATE THE FOLLOWING: - "DO NOT USE BEYOND 14 DAYS MAXIMUM DURATION OF USE." - "DO NOT SOAK, WASH, STERILIZE, OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS." - "ENSURE APPROPRIATE VENTILATOR AND FLOW SOURCE ALARMS ARE SET BEFORE CONNECTING BREATHING SET TO PATIENT." - "USE OF THE MR290 ABOVE THE MAXIMUM OPERATING PRESSURE MAY LEAD TO CRACKING, WATER LEAKAGE AND, ON RARE OCCASIONS COULD LEAD TO A LOSS OF VENTILATION PRESSURE."

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT A MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH A RT380 ADULT BREATHING CIRCUIT WAS FOUND LEAKING WATER PRIOR TO PATIENT USE. THE HEALTHCARE FACILITY IDENTIFIED A CRACK IN THE CHAMBER DOME. THERE WAS NO REPORTED PATIENT HARM.

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT A MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH A RT380 ADULT BREATHING CIRCUIT WAS FOUND LEAKING WATER PRIOR TO PATIENT USE. THE HEALTHCARE FACILITY IDENTIFIED A CRACK IN THE CHAMBER DOME. THERE WAS NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357386 FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE LTD RT380 2102757105 09420012429728

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown