BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED VENTED HUMIDIFICTION CHAMBER

    MDR report key: 1172321 · Received September 19, 2008

    Report

    Report Number
    9611451-2008-00541
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 12, 2008
    Report Date
    August 19, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED CHAMBER (1 UNIT) WAS INVERTED AND BOTH PRIMARY AND SECONDARY FLOATS OBSERVED FOR MOVEMENT. RESULTS: BOTH FLOATS REMAINED FIXED TO THE ALUMINIUM BASE WHEN THEY SHOULD HAVE MOVED. UPON INSPECTION, A LARGE BOW WAS OBSERVED ON THE EDGE OF THE ALUMINIUM BASE IMMEDIATELY TO THE LEFT OF THE HINGE BRACKET. THERE IS ALSO CRAZING IN THIS AREA. CONCLUSION: CHAMBER OVERFILLING IS A KNOWN FAILURE MODE. IMPACT DAMAGE TO THE CHAMBER, FOR INSTANCE BY DROPPING, CAN LEAD TO MISALIGNMENT AND SUBSEQUENT JAMMING OF THE VALVE FLOAT MECHANISM. THIS PREVENTS FLOAT OPERATION, ALLOWING WATER TO FILL UNCONTROLLED IN THE CHAMBER. THE BOW OBSERVED IN THE ALUMINIUM BASE INDICATES AN IMPACT. 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 LINE. FISHER & PAYKEL HEALTHCARE HAS AN OPEN CAPA ITEM TO ADDRESS MR290 CHAMBER OVERFILLING. OUR MONITORING AND TRENDING OF CHAMBER OVERFILLING HAS A RATE OF OCCURRENCE WORLDWIDE OF 0.0008% IN THE LAST YEAR TO AUGUST 2008.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED TO OUR DISTRIBUTOR THAT 2 UNITS OF THE MR290V AUTOFEED VENTED HUMIDIFICATION CHAMBER CONNECTED TO AN RT235 BREATHING CIRCUIT, OVERFILLED WITH WATER AS BOTH THE FLOATS IN THE CHAMBERS DID NOT WORK. WATER SUBSEQUENTLY ENTERED THE BREATHING CIRCUIT. ONE OF THE AFFECTED CHAMBERS WAS DISCARDED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED VENTED HUMIDIFICTION CHAMBER BTT FISHER & PAYKEL HEALTHCARE, LTD. MR290V 080418

    Patients

    Seq Age Sex Outcome Treatment
    1 INFANT EVAQUA BREATHING CIRCUIT