BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 5770703 · Received July 5, 2016

    Report

    Report Number
    9611451-2016-00307
    Event Type
    Malfunction
    Date Received
    July 5, 2016
    Date of Event
    June 3, 2016
    Report Date
    June 10, 2016
    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 A HORIZONTAL CRACK AROUND THE BASE OF THE CHAMBER DOME, BETWEEN THE HINGE BRACKET AND ONE OF THE PORTS. SMEARED PRINT WAS ALSO OBSERVED ABOVE THE CRACK LOCATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT 150923. CONCLUSION: THE NATURE OF THE CRACKING AND THE SMEARED PRINT INDICATES THAT THE CHAMBER CAME 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.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT A CRACK WAS FOUND ON AN MR290V HUMIDIFICATION CHAMBER AFTER 5 DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422764 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 1509230932

    Patients

    Seq Age Sex Outcome Treatment
    1