BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2042762 · Received April 6, 2011

    Report

    Report Number
    9611451-2011-00219
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    February 22, 2011
    Report Date
    March 9, 2011
    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). METHOD: THE COMPLAINT MR290V HUMIDIFICATION CHAMBERS HAVE NOT BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR INSPECTION. OUR ANALYSIS IS BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL. RESULTS: THE NURSE FROM THE HOSPITAL REPORTED THAT THE LEAK OBSERVED WAS DUE TO THE "HAIRLINE CRACK" IN THE WATER FEEDSET TUBE NEXT TO THE WATERBAG SPIKE. IT WAS FURTHER REPORTED THAT THE WATER FEEDSET TUBE "WAS UNDER TENSION BECAUSE NO FEED SET EXTENSION WAS USED AND THIS RESULTED IN THE CRACK." A LOT CHECK WAS NOT PERFORMED AS NO LOT INFORMATION HAD BEEN PROVIDED. CONCLUSION: WITHOUT THE RETURN OF THE COMPLAINT DEVICE, WE ARE UNABLE TO DETERMINE THE POSSIBLE ROOT CAUSE OF THE REPORTED FAULT. ALL CHAMBERS ARE PRESSURE TESTED BEFORE LEAVING 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." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE CONNECTION PORTS OF TWO MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE FOUND CRACKED. THIS WAS OBSERVED BEFORE USE ON A PATIENT. 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 MR290V NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1