BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2180134 · Received July 27, 2011

    Report

    Report Number
    9611451-2011-00442
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    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 RETURNED MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS VISUALLY INSPECTED FOR DAMAGE. RESULTS: A VISUAL INSPECTION REVEALED THAT A PART OF THE WATER FEEDSET TUBE, WHICH IS NEAR THE WATER BAG SPIKE, WAS CUT. THE WATER BAG SPIKE WAS BENT AND DAMAGED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 110118. CONCLUSION: THE SUSTAINED DAMAGE TO THE WATER FEEDSET TUBE INDICATES THAT IT WAS CUT WITH A SHARP OBJECT. THE WATER BAG SPIKE WAS MOST LIKELY EXPOSED TO HEAT, CAUSING THE DAMAGE. AS PART OF OUR MANUFACTURING PROCESS, EVERY MR290 CHAMBER UNDERGOES PRESSURE TESTING FOR POTENTIAL LEAKS AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE WATER FEEDSET TUBE AND SPIKE WERE DAMAGED POST-PRODUCTION. THE MR290 USER INSTRUCTIONS STATE THE FOLLOWING: "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "SET APPROPRIATE VENTILATOR ALARM." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT WATER LEAKED FROM THE CONNECTION BETWEEN THE BAG SPIKE AND WATER FEEDSET TUBE. THIS WAS NOTICED DURING USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 110118

    Patients

    Seq Age Sex Outcome Treatment
    1