BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2545486 · Received April 23, 2012

    Report

    Report Number
    9611451-2012-00248
    Event Type
    Malfunction
    Date Received
    April 23, 2012
    Date of Event
    March 15, 2012
    Report Date
    March 30, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBERS: 110507 X 1, 110603 X 3, 110823 X 1, NOT PROVIDED X 5. DEVICE MANUFACTURING DATE: 05/07/2011 X 1, 06/03/2011 X 3, 08/23/2011 X 1, UNKNOWN X 5. THE COMPLAINT MR290 CHAMBERS ARE EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(6). WE WILL PROVIDE A FOLLOW UP REPORT UPON RECEIPT OF THE COMPLAINT DEVICES AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBERS: 110507 X 1, 110603 X 3, 110823 X 1, NOT PROVIDED X 5. DEVICE MANUFACTURING DATE: 05/07/2011 X 1, 06/03/2011 X 3, 08/23/2011 X 1, UNKNOWN X 5. METHOD: FIVE COMPLAINT MR290 DEVICES WERE RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT 3 COMPLAINT CHAMBERS (LOT 110603) WERE CRACKED AT THE CHAMBER DOME, ALONG THE BASE. THE OTHER 2 COMPLAINT CHAMBERS (LOTS 110507 AND 110823) HAD A BREAK IN THE FEEDSET TUBE, WHERE IT CONNECTS TO THE CHAMBER. THE SURFACE AT THE BREAK IS ROUGH AND NOT SMOOTHLY CUT. THE LOT CHECKS REVEALED NO OTHER COMPLAINTS RELATING TO THE CRACKED CHAMBER DOME FOR LOT NUMBER 110603 AND NO OTHER COMPLAINTS RELATING TO BROKEN FEEDSET TUBE FOR LOT NUMBERS 110507 AND 110823. CONCLUSION: THE FEEDSET TUBE DAMAGE APPEARED TO HAVE BEEN CAUSED BY THE TUBE BEING PULLED AWAY FROM THE CHAMBER, POSSIBLY DUE TO THE FEEDSET BEING CAUGHT OR UNDER TENSION. OUR INVESTIGATION RESULTS INDICATE THAT THE CRACKING OBSERVED ON THE CHAMBERS FROM THIS COMPLAINT WAS MOST LIKELY CAUSED BY ENVIRONMENTAL STRESS CRACKING DUE TO THE CHAMBER DOME COMING INTO CONTACT WITH CLEANING PRODUCTS, SPECIFICALLY PRODUCTS THAT ARE ALCOHOL-BASED. BASED ON OUR INSPECTION OF THE RETURNED DEVICE, THE RESIDUE PRESENT ON THE CHAMBER DOME INDICATES THAT THE DOME CAME IN CONTACT WITH CLEANING SOLUTIONS CONTAINING ETHANOL, WHICH CONTRIBUTED TO 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).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT 10 MR290 AUTOFEED HUMIDIFICATION CHAMBERS WERE LEAKING WATER FROM THE CHAMBER BASE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT 10 MR290 AUTOFEED HUMIDIFICATION CHAMBERS WERE LEAKING WATER FROM THE CHAMBER BASE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1