BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 8502467 · Received April 11, 2019

    Report

    Report Number
    9611451-2019-00330
    Event Type
    Malfunction
    Date Received
    April 11, 2019
    Date of Event
    February 28, 2019
    Report Date
    March 13, 2019
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). METHOD: TWO OF THE FOUR COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS (2X LOT 180925, DEVICE MF DATE: 25 SEPT 2018) WERE RETURNED TO F&P IN NEW ZEALAND AND WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION OF THE COMPLAINT (B)(4) CHAMBERS REVEALED EACH HAD HORIZONTAL CRACKING ON THE CHAMBER DOME. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT HAD CAUSED THE DAMAGE TO THE CHAMBER DOMES; HOWEVER, OUR PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS SHOW THAT CRACKS ON THE CHAMBER DOME CAN BE DUE TO THE APPLICATION OF EXCESSIVE PRESSURE. THE INTEGRITY OF THE CHAMBER CAN BE AFFECTED WHEN PRESSURE EXCEEDS 80CMH2O. EVERY MR290 CHAMBER IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DOME 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 CHAMBERS WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE (B)(4) VENTED AUTOFEED HUMIDIFICATION CHAMBER STATE THE FOLLOWING: - "DO NOT SOAK, WASH, STERILIZE, OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS." - "SET APPROPRIATE VENTILATOR ALARMS." - "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 GERMANY REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT FOUR MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS HAD A LEAK AND DROPPED WATER ON THE GROUND. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). TWO OF THE FOUR COMPLAINT MR290 CHAMBERS (2X BATCH NUMBER 2100593061) ARE EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION, WHILE THE OTHER TWO COMPLAINT CHAMBERS WERE DESTROYED BY THE CUSTOMER FOLLOWING THE EVENT. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT FOUR MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS HAD A LEAK AND DROPPED WATER ON THE GROUND. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297724 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 F&P MR850 RESPIRATORY HUMIDIFIER| F&P MR850 RESPIRATORY HUMIDIFIER| F&P RT330 INFANT NASAL HIGH FLOW SYSTEM| F&P RT330 INFANT NASAL HIGH FLOW SYSTEM