BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1960464 · Received January 13, 2011

    Report

    Report Number
    9611451-2011-00028
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 20, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR290VX VENTED AUTOFEED HUMIDIFICATION CHAMBERS HAD BEEN DESTROYED AT THE HEALTHCARE FACILITY. WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION FROM THE HEALTHCARE FACILITY IN ORDER TO ASSIST US WITH THE ANALYSIS AND IDENTIFICATION OF A POSSIBLE ROOT CAUSE OF THE EVENT AS REPORTED. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE RECEIVE FURTHER INFORMATION AND HAVE COMPLETED OUR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR290VX VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE NOT RETURNED TO FPH (B)(4) FOR INVESTIGATION. OUR ANALYSIS IS ACCORDINGLY BASED ONLY ON THE EVENT DESCRIPTION PROVIDED BY THE HEALTHCARE FACILITY. THE HEALTHCARE FACILITY REPORTED THAT THE WATER FEEDSET SPIKES OF THREE MR290VX VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE FOUND LEAKING DURING USE. WITHOUT THE COMPLAINT DEVICE IT IS NOT POSSIBLE TO DETERMINE IF THE LEAK IN THE WATER FEEDSET TUBE CONNECTION IS DUE TO PHYSICAL DAMAGE, INCORRECT ASSEMBLY OR OTHER CAUSES. ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. OUR USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 STATE THE FOLLOWING: "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." NO PATIENT CONSEQUENCE WAS REPORTED AS A RESULT OF THIS INCIDENT. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO AN FPH FIELD REPRESENTATIVE THAT THE WATER FEEDSET SPIKES OF THREE MR290VX VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE FOUND LEAKING DURING USE. IT WAS ALSO REPORTED THAT THE MR290VX CHAMBERS HAVE BEEN DESTROYED BY THE HEALTHCARE FACILITY. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO AN FPH FIELD REPRESENTATIVE THAT THE WATER FEEDSET SPIKES OF THREE MR290VX VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE FOUND LEAKING DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290VX 101001

    Patients

    Seq Age Sex Outcome Treatment
    1