BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 2996194 · Received March 10, 2013

    Report

    Report Number
    9611451-2013-00175
    Event Type
    Malfunction
    Date Received
    March 10, 2013
    Date of Event
    December 17, 2012
    Report Date
    February 11, 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 COMPLAINT MR290 CHAMBER WAS RECEIVED. THE CHAMBER WAS VISUALLY INSPECTED. RESULTS: INSPECTION OF THE COMPLAINT FEEDSET TUBE REVEALED THAT THERE WAS ADEQUATE GLUE ON THE FEEDSET TUBE/SPIKE CONNECTION BUT THE GLUE WAS NOT BONDING. A LOT CHECK REVEALED TWO OTHER COMPLAINTS OF THIS NATURE FOR LOT 120419. 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 WATER LEAKED FROM THE CONNECTION BETWEEN THE BAG SPIKE AND THE WATER FEED TUBE OF AN MR290 HUMIDIFICATION CHAMBER AFTER SIX DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100866 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 1204190105

    Patients

    Seq Age Sex Outcome Treatment
    1