BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1759397 · Received June 23, 2010

    Report

    Report Number
    9611451-2010-00389
    Event Type
    Malfunction
    Date Received
    June 23, 2010
    Date of Event
    May 20, 2010
    Report Date
    May 27, 2010
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE MR290 CHAMBER WAS VISUALLY INSPECTED FOR DAMAGE OR DEFORMITIES. RESULTS: ONE OF THE TWO PORTS ON THE MR290 CHAMBER WAS BENT INWARDS. THE AREA AROUND THE BASE OF THE DEFORMED CHAMBER PORT WAS SMOOTH AND FREE OF STRESS MARKS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 090223. CONCLUSION: THE CHAMBER PORT WAS DEFORMED AND BENT OVER. THE AREA AROUND THE PORT WAS SMOOTH SUGGESTING THAT THE PORT HAD DEFORMED DUE TO EXPOSURE TO HEAT RATHER THAN FORCE, WHICH WOULD HAVE CAUSED STRESS MARKS OR CRACKING. IT IS LIKELY THAT A FLOW RESTRICTOR VALVE WAS ATTACHED TO THE CHAMBER PORT AS PART OF THE BREATHING CIRCUIT SET-UP. IN THE EVENT THAT FLOW THROUGH THE CHAMBER IS CEASED FOR A PERIOD OF TIME (DUE TO INCORRECT VENTILATOR SETTINGS OR FLOW RESTRICTOR VALVE FAILURE), AN INCREASE OF TEMPERATURE INSIDE OF THE CHAMBER CAN OCCUR. IN THIS EVENT, THE CHAMBER CAN SOFTEN AND BE BENT BY THE WEIGHT OF THE RESTRICTOR ON TOP OF THE PORT. THE DETAILS OF HUMIDIFIER WERE NOT SUPPLIED WITH THE COMPLAINT HOWEVER ALL FISHER AND PAYKEL HEALTHCARE HUMIDIFIERS CONTAIN BOTH SOFTWARE AND MANUAL TEMPERATURE CONTROL MEASURES INCLUDING THERMAL CUT OUT SWITCHES TO PREVENT OVER HEATING.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT ONE OF THE PORTS ON AN MR290 AUTOFEED HUMIDIFICATION CHAMBER WAS DEFORMED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED HUMIDIFICATION CHAMBER BTT FISHER & PAYKEL HEALTHCARE, LTD. MR290V 090223

    Patients

    Seq Age Sex Outcome Treatment
    1