BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3022243 · Received March 26, 2013

    Report

    Report Number
    9611451-2013-00212
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 25, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    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 DEVICE IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLIANT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE IT WAS VISUALLY INSPECTED FOR THE REPORTED DAMAGE. RESULTS: VISUAL INSPECTION REVEALED A CRACK ON THE CHAMBER DOME BELOW ONE OF THE PORTS. THE CRACK STRETCHED ALONG THE BASE OF THE CHAMBER. A SMALL AMOUNT OF RESIDUE WAS IDENTIFIED NEAR THE CRACK AND ON THE CHAMBER DOME. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120427. CONCLUSION: BASED ON THE RESIDUE AND THE NATURE OF THE CRACKING OBSERVED ON THE RETURNED MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER, WE CAN CONCLUDE THAT THE DAMAGE WAS CAUSED BY ENVIRONMENTAL STRESS CRACKING DUE TO THE CHAMBER DOME COMING INTO CONTACT WITH ALCOHOL BASED CLEANING SOLUTIONS. THE HOSPITAL HAS FURTHER INFORMED US THAT THE RETURNED MR290V CHAMBER MAY HAVE COME IN CONTACT WITH A DISINFECTION SOLUTION AND THAT THE CRACK WAS ONLY NOTICED AFTER TWO TO THREE DAYS OF USE. THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER IS A SINGLE USE DEVICE, MANUFACTURED IN A CLEAN WORKING ENVIRONMENT AND DOES NOT REQUIRE ANY CLEANING. TO THIS END OUR USER INSTRUCTIONS STATE: "DO NOT SOAK, WASH, STERILISE OR REUSE THIS PRODUCT." EVERY MR290 CHAMBER IS PRESSURE TESTED TO 8KPA 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 8KPA. OUR MONITORING AND TRENDING OF COMPLAINTS INVOLVING CRACKED DOMES IN MR290 CHAMBERS DUE TO ENVIRONMENTAL STRESS CRACKING HAS A RATE OF OCCURRENCE OF (B)(4) SOLD WORLDWIDE IN THE LAST YEAR TO THE END OF MAY 2013.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT A CRACK WAS FOUND ON AN MR290 AUTOFEED HUMIDIFICATION CHAMBER. THIS WAS FOUND AFTER TWO TO THREE DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT A CRACK WAS FOUND ON AN MR290 AUTOFEED HUMIDIFICATION CHAMBER. THIS WAS FOUND AFTER TWO TO THREE DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124581 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 120427

    Patients

    Seq Age Sex Outcome Treatment
    1 MR850 RESPIRATORY HUMIDIFIER