BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1083133 · Received July 24, 2008

    Report

    Report Number
    9611451-2008-00455
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 10, 2008
    Report Date
    July 9, 2008
    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

    THE MR290V CHAMBER WAS TESTED FOR OVERFILLING BY CONNECTION WITH A WATERFEED BAG. THE CHAMBER FUNCTIONED CORRECTLY -THE PRIMARY FLOAT STOPPED THE WATER FROM RISING ABOVE THE MAXIMUM FILL LINE. THERE IS NO VISIBLE DAMAGE TO THE ALUMINIUM BASE OF THE CHAMBER. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: OVERFILLING IS CAUSED BY BOTH THE PRIMARY AND SECONDARY FLOAT MECHANISMS IN THE MR290 CHAMBER BEING DISABLED. IMPACT DAMAGE CAN LEAD TO MISALIGNMENT AND SUBSEQUENT JAMMING OF THE VALVE FLOAT MECHANISM, ALLOWING WATER TO FILL THE CHAMBER UNIMPEDED. IT IS POSSIBLE THE FLOATS IN THIS CHAMBER WERE JAMMED INITIALLY. HOWEVER, VIBRATIONS DURING TRANSPORT COULD HAVE RE-ALIGNED THE VALVE FLOATS AND ALLOW THE FLOATS TO FUNCTION. OUR INSTRUCTIONS FOR USE INDICATE IN PICTORIAL FORM THE MAXIMUM FILL LINE AND ADVISES THE USER TO REPLACE THE CHAMBER SHOULD WATER EXCEED THE LIMIT INE. CURRENTLY, FISHER & PAYKEL HEALTHCARE HAS AN OPEN CAPA ITEM TO ADDRESS MR290 CHAMBER OVERFILLING. THE DESIGN OF A MODIFIED MR290 CHAMBER HAS BEEN APPROVED FOR MANUFACTURE. OUR MONITORING AND TRENDING OF MR290 CHAMBER OVERFILLING HAS A RATE OF OCCURRENCE WORLDWIDE FOR THE LAST YEAR OF 0.001%.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED TO OUR DISTRIBUTOR THAT AN MR290V AUTOFEED HUMIDIFICATION CHAMBER ("THE CHAMBER") FILLED WITH WATER BEYOND THE MAXIMUM WATER LINE. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED HUMIDIFICATION CHAMBER BTT FISHER & PAYKEL HEALTHCARE, LTD. MR290V 080131

    Patients

    Seq Age Sex Outcome Treatment
    1