BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1053655 · Received May 27, 2008

    Report

    Report Number
    9611451-2008-00329
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 24, 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 ACTUAL COMPLAINT DEVICE WAS EVALUATED. THE WATER BAG SPIKE THAT PENETRATES THE WATER BAG HAD BEEN CUT OFF AND NOT RETURNED. A NEW WATER BAG SPIKE AND WATERFEED TUBE WERE ATTACHED TO DO A PERFORMANCE TEST ON THE CHAMBER FLOAT OPERATION TO SEE IF WATER WOULD FILL CORRECTLY IN THE CHAMBER. RESULTS - THE CHAMBER FLOAT OPERATES CORRECTLY AND ALLOWS WATER TO FILL IN THE CHAMBER TO AN ACCEPTABLE LEVEL. CONCLUSION - NO MALFUNCTION WAS DETECTED IN THE CHAMBER FLOAT OPERATION CONTROLLING WATER LEVEL. HOWEVER, AS THE WATER BAG SPIKE WAS NOT RETURNED, WE WERE UNABLE TO EVALUATE ITS PERFORMANCE. IT IS LIKELY THE VALVE INSIDE THE WATER BAG SPIKE WAS NOT EQUALIZING PRESSURE CORRECTLY WHICH COULD REDUCE WATER FLOW TO THE CHAMBER.

    Description of Event or Problem · 1

    A HOSPITAL IN ANOTHER COUNTRY, REPORTED TO OUR DISTRIBUTOR THAT THE MR290 HUMIDIFICATION CHAMBER WAS NOT FILLING CORRECTLY WHEN THE WATER BAG BECAME LOW ON WATER. 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. MR290 071113

    Patients

    Seq Age Sex Outcome Treatment
    1