BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 17339746 · Received July 17, 2023

    Report

    Report Number
    9611451-2023-00654
    Event Type
    Malfunction
    Date Received
    July 17, 2023
    Date of Event
    June 3, 2023
    Report Date
    July 11, 2023
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    UDI-DI
    09420012431080
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF COMPLETING OUR INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). CORRECTED DATA: SECTION B5. DESCRIBE EVENT OR PROBLEM: A HEALTHCARE FACILITY IN CHINA REPORTED THAT THE WATER FEEDSET OF A MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER FROM RT225 INFANT BIAS FLOW BREATHING CIRCUIT WAS FOUND BROKEN AT THE CONNECTION BETWEEN WATER FEEDSET TUBE AND CHAMBER BEFORE PATIENT USE. SECTION D1. BRAND NAME: VENTED HUMIDIFICATION CHAMBER. SECTION D2. COMMON DEVICE NAME: AUTOFEED CHAMBER. SECTION D2. PRODUCT CODE: BTT. SECTION D4. MODEL NUMBER, CATALOG NUMBER: MR290V. SECTION G4. PMA/510(K): K934140. METHOD: THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. OUR INVESTIGATION IS THEREFORE BASED ON THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY, AND OUR KNOWLEDGE OF THE PRODUCT. RESULT: THE HEALTHCARE FACILITY REPORTED THAT THE WATER FEEDSET OF A MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER FROM RT225 INFANT BIAS FLOW BREATHING CIRCUIT WAS FOUND BROKEN AT THE CONNECTION BETWEEN WATER FEEDSET TUBE AND CHAMBER BEFORE PATIENT USE. CONCLUSION: WITHOUT THE RETURN OF THE COMPLAINT DEVICE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. EVERY MR290V 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 SUBJECT MR290V CHAMBER WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER STATE THE FOLLOWING: "ENSURE APPROPRIATE VENTILATOR OR FLOW SOURCE ALARMS ARE SET BEFORE CONNECTING BREATHING SET TO PATIENT." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT."

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN CHINA REPORTED THAT THE TUBING OF A RT225 INFANT BIAS FLOW BREATHING CIRCUIT WAS FOUND BROKEN BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN CHINA REPORTED THAT THE WATER FEEDSET OF A MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER FROM RT225 INFANT BIAS FLOW BREATHING CIRCUIT WAS FOUND BROKEN AT THE CONNECTION BETWEEN WATER FEEDSET TUBE AND CHAMBER BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754749 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 2102390155 09420012431080
    772330 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 2102390155 09420012431080

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA Male F&P RT225 INFANT BIAS FLOW BREATHING CIRCUIT