BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 3157859 · Received June 9, 2013

    Report

    Report Number
    9611451-2013-00462
    Event Type
    Malfunction
    Date Received
    June 9, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    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 MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FPH IN (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE WATERBAG SPIKE WAS SEPARATED FROM THE WATER FEEDSET TUBE. SUFFICIENT AMOUNT OF GLUE WAS FOUND ON THE SPIKE TUBING CONNECTION; HOWEVER, THE GLUE WAS NOT BONDING. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 130115. 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 AFTER RELEASE FOR DISTRIBUTION, 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 TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE WATER BAG SPIKE WAS FOUND DETACHED FROM THE WATER FEEDSET TUBE OF AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER. THIS WAS OBSERVED BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259201 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 130115

    Patients

    Seq Age Sex Outcome Treatment
    1