BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2435547 · Received February 1, 2012

    Report

    Report Number
    9611451-2012-00049
    Event Type
    Malfunction
    Date Received
    February 1, 2012
    Date of Event
    December 1, 2011
    Report Date
    January 5, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED COMPLAINT MR290V CHAMBER WAS VISUALLY INSPECTED. RESULTS: THE CHAMBER DOME WAS CRACKED BELOW ONE OF THE PORTS, WHICH STRETCHED ALONG THE BASE. FURTHER INSPECTION REVEALED THAT IT HAD SLIGHTLY SMEARED PRINT ABOVE THE CRACK. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 110729. CONCLUSION: WE HAVE RECENTLY COMPLETED AN INVESTIGATIONS INTO THE CRACKING OF THE MR290V CHAMBERS. OUR INVESTIGATION RESULTS INDICATE THAT THE CRACKING OBSERVED ON THE CHAMBERS FROM THE COMPLAINTS IN THIS ENQUIRY WERE MOST LIKELY CAUSED BY ENVIRONMENTAL STRESS CRACKING DUE TO THE CHAMBER DOMES COMING INTO CONTACT WITH CLEANING PRODUCTS, SPECIFICALLY PRODUCTS THAT ARE ALCOHOL-BASED. BASED ON THE INSPECTION OF THE RETURNED DEVICE, THE SMEARED PRINT ON THE CHAMBER DOME INDICATES THAT AN ALCOHOL-BASED PRODUCT CAME IN CONTACT WITH THE CHAMBER, POSSIBLY THE HOSPITAL STAFF HAD DISINFECTED THEIR HANDS BEFORE TOUCHING THE CHAMBER. IT IS OUR INTENTION TO CONTACT THE HOSPITAL IN ORDER TO EDUCATE ABOUT THE SAFE USE OF THESE CLEANING PRODUCTS, SO AS TO PREVENT THE CHAMBERS FROM COMING INTO CONTACT WITH SUCH PRODUCTS. THE MR290 HUMIDIFICATION CHAMBER IS A SINGLE USE DEVICE, MANUFACTURED IN A CLEAN WORKING ENVIRONMENT AND AS SUCH DOES NOT NEED TO BE CLEANED. TO THIS END, OUR USER INSTRUCTIONS STATE: "DO NOT SOAK, WASH, STERILISE OR REUSE THIS PRODUCT." EVERY MR290 CHAMBER IS PRESSURE TESTED TO 200CMH20 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. THIS SUGGESTS THAT THE CRACKS OCCURRED POST PRODUCTION. FISHER & PAYKEL HEALTHCARE'S USER INSTRUCTIONS THAT ACCOMPANY THE MR290 CHAMBER SPECIFY TO THE USER TO "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM BEFORE CONNECTING TO A PATIENT", TO REFRAIN FROM USING THE CHAMBER IF IT HAS BEEN DROPPED AND "TO SET THE APPROPRIATE VENTILATOR ALARMS" IN THE EVENT A LEAK OCCURS. IT ALSO STATES THAT THE MAXIMUM OPERATING PRESSURE IS 8KPA.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT WATER LEAKED AT THE BASE OF AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 110729

    Patients

    Seq Age Sex Outcome Treatment
    1