BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 2938696 · Received January 31, 2013

    Report

    Report Number
    9611451-2013-00070
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    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 TWO COMPLAINT MR290 CHAMBERS WAS RECEIVED, ONE FROM LOT 120525 AND ONE FROM LOT 120530 (MANUFACTURED MAY 30, 2012). THE CHAMBERS WERE VISUALLY INSPECTED. RESULTS: IN BOTH CASES THE WATER BAG SPIKE WAS COMPLETELY SEPARATED FROM THE WATER FEEDSET TUBE. ADEQUATE GLUE WAS FOUND ON THE FEEDSET TUBE/SPIKE CONNECTION BUT THE GLUE WAS NOT BONDING. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT 120530, BUT NO OTHER COMPLAINTS FOR LOT 120525. 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 SPIKE BECAME LOOSE 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." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE WATER FEED TUBE OF AN MR290 HUMIDIFICATION CHAMBER BECAME SEPARATED FROM THE BAG SPIKE DURING USE AND THAT THIS OCCURED IN TWO CASES. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42800 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 120525

    Patients

    Seq Age Sex Outcome Treatment
    1