BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2122569 · Received June 13, 2011

    Report

    Report Number
    9611451-2011-00353
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Report Date
    May 20, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WATER FEEDSET TUBES AND WATERBAG SPIKES OF THE AFFECTED MR290VX CHAMBERS ARE NOT EXPECTED TO BE RETURNED TO FPH (B)(4) FOR INVESTIGATION AS THE HOSPITAL REPORTED THAT THE SUBJECT PARTS WERE "CUT OFF AND THROWN AWAY." WITHOUT THE COMPLAINT WATER FEEDSET TUBES AND WATERBAG SPIKES, WE ARE UNABLE TO ESTABLISH THE ROOT CAUSE OF THE REPORTED FAULT. ALL CHAMBERS ARE PRESSURE TESTED BEFORE LEAVING THE PRODUCTION LINE. ANY HOLES OR LEAKS IN THE WATER FEEDSET TUBES ARE IDENTIFIED DURING THIS AUTOMATED PROCESS. THE CHAMBERS, INCLUDING THE WATER FEEDSET TUBES, WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS SUPPLIED WITH THE MR290 HUMIDIFICATION CHAMBER STATE THE FOLLOWING: "SET APPROPRIATE VENTILATOR ALARMS." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE WATER FEEDSETS OF TWO MR290VX VENTED AUTOFEED HUMIDIFICATION CHAMBERS LEAKED WHEN ATTACHED TO A WATERBAG. THIS WAS NOTICED PRIOR TO PATIENT USE. IT WAS FURTHER REPORTED THAT THE HOSPITAL "HAD KEPT THE CHAMBERS BUT CUT OFF AND THROWN AWAY THE SPIKES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290VX 101014

    Patients

    Seq Age Sex Outcome Treatment
    1