BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2855101 · Received December 3, 2012

    Report

    Report Number
    9611451-2012-00751
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 26, 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). PLEASE NOTE AN INITIAL REPORT WAS SUBMITTED ON (B)(4) 2012. DUE TO AN ERROR IT WAS SUBMITTED VIA THE TEST GATEWAY. PLEASE CONSIDER THIS AS THE INITIAL/FINAL REPORT FOR THIS COMPLAINT. METHOD: THE COMPLAINT MR290V CHAMBER WAS RETURNED TO FPH IN (B)(4) AND WAS VISUALLY INSPECTED FOR THE REPORTED DAMAGE. RESULTS: VISUAL INSPECTION REVEALED THAT THE SPIKE AND THE FEEDSET TUBING WERE RETURNED SEPARATED FROM EACH OTHER. SUFFICIENT GLUE WAS PRESENT AROUND THE SPIKE TUBING CONNECTION; HOWEVER THE GLUE HAD NOT BONDED PROPERLY. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120417. CONCLUSION: THE SEPARATION OF THE SPIKE AND FEEDSET TUBE WAS DUE TO THE FAILURE OF THE GLUE BOND. WE WERE UNABLE TO DETERMINE THE CAUSE FOR THIS. 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 FAILURE OF THE BOND DEVELOPED POST PRODUCTION. 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) REPRESENTATIVE THAT THE WATER FEED SET TUBE FELL OFF THE BAG SPIKE WHEN EXCHANGING THE WATER BAG. THIS WAS FOUND AFTER SIX DAYS 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 120417

    Patients

    Seq Age Sex Outcome Treatment
    1 BABYLOG 8000 VENTILATOR