BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 3332737 · Received September 9, 2013

    Report

    Report Number
    9611451-2013-00678
    Event Type
    Malfunction
    Date Received
    September 9, 2013
    Date of Event
    August 22, 2013
    Report Date
    August 26, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290 CHAMBER WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. WE WERE INFORMED THAT THE HOSPITAL HAD DESTROYED THE DEVICE. THE HOSPITAL PROVIDED A PHOTOGRAPH FOR OUR EVALUATION. RESULTS: THE PHOTOGRAPH PROVIDED BY THE HOSPITAL WAS OF POOR RESOLUTION. IT SHOWED THE PART OF THE FEEDSET TUBE WHERE IT CONNECTS TO THE SPIKE. HOWEVER NO MALFUNCTION OF THE FEEDSET TUBE WAS VISIBLE. THE TUBE APPEARED INTACT AND NO WATER DROPS WERE VISIBLE. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT 130328. CONCLUSION: IN THE ABSENCE OF A DEVICE WE WERE UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM REPORTED BY THE CUSTOMER. WE HAVE CONDUCTED EXTENSIVE TESTING OF THE MR290 CHAMBER, WITH PARTICULAR EMPHASIS ON FEEDSET BREAKS. SIGNIFICANTLY WE HAVE NOT BEEN ABLE TO REPLICATE FAILURE OF THE FEEDSET TUBE AT THE CHAMBER DOME IN ANY OF OUR TESTING. (B)(4). ADDITIONALLY ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. CHAMBERS THAT FAIL ANY OF THESE TESTS ARE DISCARDED. 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."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE WATER FEED TUBE OF AN MR290 HUMIDIFICATION CHAMBER WAS LEAKING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450681 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 130328

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL RT235 BREATHING CIRCUIT KIT