BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 4650091 · Received April 1, 2015

    Report

    Report Number
    9611451-2015-00182
    Event Type
    Malfunction
    Date Received
    April 1, 2015
    Date of Event
    March 5, 2015
    Report Date
    March 6, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FPH IN (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: NO FAULT WAS FOUND WITH THE SPIKE OF THE RETURNED CHAMBER, WHICH WAS STILL CONNECTED TO A WATER BAG WHEN RECEIVED. THE SPIKE WAS REMOVED FROM THE WATER BAG SUCCESSFULLY. FURTHER INSPECTION REVEALED THAT THE ALUMINIUM BASE HAD A SLIGHT DENT. CRACKING AND CRAZING WERE ALSO OBSERVED ON THE CHAMBER DOME. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 140920. CONCLUSION: THE NATURE OF THE CRACKING AND CRAZING ON THE CHAMBER DOME INDICATES THAT THE DAMAGE WAS CAUSED BY THE CHAMBER COMING INTO CONTACT WITH A SOLUTION CONTAINING ETHANOL/ALCOHOL WHICH HAS RESULTED IN ENVIRONMENTAL STRESS CRACKING OF THE CHAMBER DOME. EVERY MR290 CHAMBER IS PRESSURE TESTED TO 200 CMH2O 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. 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." "MAXIMUM OPERATING PRESSURE: 8 KPA." OUR MONITORING AND TRENDING OF COMPLAINTS INVOLVING ENVIRONMENTAL STRESS CRACKING IN MR290 CHAMBERS HAS A RATE OF OCCURRENCE OF (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) PRODUCT SPECIALIST THAT THE WATER BAG SPIKE OF AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER COULD NOT BE DISCONNECTED FROM THE WATER BAG AFTER IT WAS USED ON A PATIENT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) PRODUCT SPECIALIST THAT THE WATER BAG SPIKE OF AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER COULD NOT BE DISCONNECTED FROM THE WATER BAG AFTER IT WAS USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214165 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 140920

    Patients

    Seq Age Sex Outcome Treatment
    1