BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 10067925 · Received May 18, 2020

    Report

    Report Number
    9611451-2020-00482
    Event Type
    Malfunction
    Date Received
    May 18, 2020
    Date of Event
    April 16, 2020
    Report Date
    April 23, 2020
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PS339155 D4 CORRECTION: THE LOT NUMBER WAS CORRECTED FROM 2100917188 TO 190604 AND 190605. DEVICE 1: LOT 190604 DOM 06/04/2019 DEVICE 2: LOT 190605 DOM 06/05/2019 DEVICE 3-6: LOT UNKNOWN, NOT PROVIDED. METHOD: THREE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) IN NEW ZEALAND AND WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION OF DEVICES 1 AND 2 REVEALED THAT THE RETURNED DEVICES HAD A CRACKED DOME. IT WAS ALSO FOUND THAT THE INK OF CHAMBERS 1 AND 2 WERE SMEARED. THERE WAS NO FAULT FOUND WITH DEVICE 3. CONCLUSION: THE CRACKED DOME FOUND WITH DEVICES 1 AND 2 WERE MOST LIKELY CAUSED BY CONTACT WITH AN UNKNOWN SOLVENT, AS INDICATED BY THE SMEARED INK. BASED ON PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, SOLVENTS THAT CONTAINS ALCOHOL CAN ATTACK DOME MATERIAL AND SUBSEQUENTLY CAUSE THE DOME TO CRACK. THERE WAS NO FAULT FOUND WITH DEVICE 3. 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 MR290V 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 SWITZERLAND REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT SIX MR290 VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE BROKEN AND LEAKING WATER. THERE WAS NO PATIENT CONSEQUENCE.

    Additional Manufacturer Narrative · 1

    PS339155. THE COMPLAINT MR290 VENTED AUTOFEED HUMIDIFICATION CHAMBERS ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. 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 SIX MR290 VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE BROKEN AND LEAKING WATER. DURING DEVICE ASSESSMENT AT OUR REGIONAL OFFICE IN (B)(6), TWO MR290V CHAMBERS DISPLAYED CRACKS NEAR THE BOTTOM OF THE CHAMBER. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531913 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT MR290 190604,190605

    Patients

    Seq Age Sex Outcome Treatment
    1 F&P BC160-10 BUBBLE CPAP DELIVERY SYSTEM| F&P BC160-10 BUBBLE CPAP DELIVERY SYSTEM| F&P MR850 RESPIRATORY HUMIDIFER| F&P MR850 RESPIRATORY HUMIDIFER