BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2968817 · Received February 19, 2013

    Report

    Report Number
    9611451-2013-00130
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 25, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: ONE OF THE FOUR COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WAS RETURNED TO FPH IN (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE CHAMBER DOME WAS CRACKED ALONG THE BASE, BETWEEN THE BRACKET AND ONE OF THE PORTS. THE CHAMBER HAD SMEARED PRINTING IN THE VICINITY OF THE CRACKING. A RESIDUE WAS ALSO FOUND ON THE CRACKING. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120413. CONCLUSION: BASED ON THE NATURE OF THE CRACKING, SMEARED PRINTING, AND RESIDUE OBSERVED ON THE RETURNED CHAMBER, IT CAN BE CONCLUDED THAT THE DAMAGE WAS CAUSED BY ENVIRONMENTAL STRESS CRACKING DUE TO THE CHAMBER DOME COMING INTO CONTACT WITH CLEANING PRODUCTS, SPECIFICALLY PRODUCTS THAT ARE ALCOHOL-BASED. THE SMEARED PRINTS ON THE CHAMBER DOME INDICATE THAT THE DOME CAME IN CONTACT WITH CLEANING SOLUTIONS CONTAINING ETHANOL, WHICH RESULTED IN THE CRACKING OF THE CHAMBER. 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 (B)(4) 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. 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 (B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT A WATERBAG WAS EMPTIED TOO QUICKLY WHEN IT WAS CONNECTED TO AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER DURING SET-UP. WHEN THE CHAMBER WAS CHECKED, IT WAS OBSERVED THAT THE DOME WAS CRACKED. THIS HAPPENED ON FOUR MR290 CHAMBERS.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT A WATERBAG WAS EMPTIED TOO QUICKLY WHEN IT WAS CONNECTED TO AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER DURING SET-UP. WHEN THE CHAMBER WAS CHECKED, IT WAS OBSERVED THAT THE DOME WAS CRACKED. THIS HAPPENED ON FOUR MR290 CHAMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72080 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 120413

    Patients

    Seq Age Sex Outcome Treatment
    1