BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2478622 · Received March 5, 2012

    Report

    Report Number
    9611451-2012-00126
    Event Type
    Malfunction
    Date Received
    March 5, 2012
    Date of Event
    January 30, 2012
    Report Date
    February 10, 2012
    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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290 CHAMBER WAS RECEIVED, VISUALLY INSPECTED AND CONNECTED TO A WATER BAG FOR TESTING. RESULTS: DURING PERFORMANCE TESTING A DROP OF WATER BEGAN TO BUILD UP AT THE CONNECTION BETWEEN THE WATER FEEDSET TUBE AND SPIKE. VISUAL INSPECTION REVEALED THAT SUFFICIENT GLUE WAS PRESENT AROUND THE SPIKE TUBING CONNECTION, BUT THAT THE GLUE WAS ONLY PARTIALLY BONDED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100524. CONCLUSION: WE WERE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED FAULT. ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. THIS SUGGESTS THAT THE LEAK DEVELOPED POST PRODUCTION, LIKELY AS A RESULT OF FAILURE OF THE GLUE BOND THAT JOINS THE SPIKE TO THE WATER FEEDSET TUBE. THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 CHAMBER STATE THE FOLLOWING: "SET APPROPRIATE VENTILATOR ALARM." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." OUR MONITORING AND TRENDING OF LOOSE WATER BAG SPIKES IN MR290 CHAMBERS HAS A RATE OF OCCURRENCE OF (B)(4) DEVICES PER MILLION SOLD IN THE LAST YEAR TO THE END OF FEBRUARY 2012.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT WATER LEAKED AT THE CONNECTION BETWEEN THE WATER FEED TUBE AND THE BAG SPIKE OF AN MR290 AUTOFEED HUMIDIFICATION CHAMBER IMMEDIATELY AFTER START OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 100524

    Patients

    Seq Age Sex Outcome Treatment
    1