BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBERS

    MDR report key: 2368359 · Received December 12, 2011

    Report

    Report Number
    9611451-2011-00770
    Event Type
    Malfunction
    Date Received
    December 12, 2011
    Date of Event
    November 14, 2011
    Report Date
    November 15, 2011
    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 · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBERS: 110706, 110709, 110714, 110729, 110913. DEVICE MANUFACTURER DATES: 07/06/2011, 07/09/2011, 07/14/2011, 07/29/2011, 09/13/2011. QUANTITY SENT TO FPH (B)(4): 1, 2, 1, 1, 3. METHOD: EIGHT COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO FPH IN (B)(4) FOR INSPECTION. THE RETURNED CHAMBERS WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT ALL CHAMBERS WERE CRACKED ALONG THE BASE OF THE DOME. FURTHER INSPECTION REVEALED THAT FOUR OF THE CHAMBERS RECEIVED HAD SMEARED PRINTS. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 110706. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 110709. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 110714. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 110729. A LOT CHECK REVEALED TWO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 110913. 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 DEVICES, THE SMEARED PRINTS ON THE CHAMBER DOMES INDICATE THAT AN ALCOHOL-BASED PRODUCT CAME IN CONTACT WITH THE CHAMBERS, POSSIBLY THE HOSPITAL STAFF HAD DISINFECTED THEIR HANDS BEFORE TOUCHING THE CHAMBERS. 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 EIGHT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE FOUND LEAKING. THIS WAS NOTICED DURING USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT EIGHT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE FOUND LEAKING. THIS WAS NOTICED DURING USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED HUMIDIFICATION CHAMBERS BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V REFER TO H10

    Patients

    Seq Age Sex Outcome Treatment
    1