BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 5164618 · Received October 21, 2015

    Report

    Report Number
    9611451-2015-00440
    Event Type
    Malfunction
    Date Received
    October 21, 2015
    Date of Event
    September 22, 2015
    Report Date
    September 24, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    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 COMPLAINT MR290 CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED VERTICAL CRACKS AROUND THE BASE OF THE CHAMBER DOME. CRACKS WERE OBSERVED BELOW ONE PORT AND ALSO BETWEEN THE HINGE BRACKET AND THE OTHER PORT OF THE CHAMBER. RESIDUE WAS PRESENT ON THE INNER AND OUTER SURFACE OF THE CHAMBER DOME. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT 150407. CONCLUSION: THE NATURE OF THE CRACKING AND THE RESIDUE ON THE DOME INDICATES THAT THE DAMAGE WAS CAUSED BY THE CHAMBER COMING INTO CONTACT WITH A SOLUTION CONTAINING ETHANOL/ALCOHOL WHICH HAS RESULTED IN ENVIRONMENTAL STRESS CRACKING OF THE CHAMBER DOME. EVERY MR290 CHAMBER IS PRESSURE TESTED TO 200 CMH2O 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. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER STATE THE FOLLOWING: - DO NOT SOAK, WASH, STERILIZE, OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS. - SET APPROPRIATE VENTILATOR ALARMS. - PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT. - MAXIMUM OPERATING PRESSURE: 8 KPA. OUR MONITORING AND TRENDING OF COMPLAINTS INVOLVING ENVIRONMENTAL STRESS CRACKING IN MR290 CHAMBERS HAS A RATE OF OCCURRENCE OF 9 DEVICES PER MILLION SOLD WORLDWIDE IN THE LAST YEAR TO THE END OF (B)(4) 2015.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT AN MR290V HUMIDIFICATION CHAMBER DOME BROKE AFTER EIGHT DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696404 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 1504070306

    Patients

    Seq Age Sex Outcome Treatment
    1