BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3725029 · Received April 3, 2014

    Report

    Report Number
    9611451-2014-00297
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 7, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: TWO MR290 AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. THE CHAMBERS WERE VISUALLY INSPECTED FOR DAMAGE AND PRESSURE TESTED. RESULTS: NO DAMAGE WAS FOUND TO ANY PART OF THE RETURNED CHAMBERS. THE PRESSURE TEST REVEALED THAT THE CHAMBERS WERE WITHIN SPECIFICATION. UPON THE RETURN OF THE DEVICES THE LOT DATE OF THE MR290 AUTOFEED HUMIDIFICATION CHAMBERS WAS NOTED TO BE 130912 (12 SEPTEMBER 2013). NO COMPLAINTS HAVE BEEN RECEIVED FOR THIS LOT DATE. CONCLUSION: WE COULD FIND NO FAULT WITH THE CHAMBERS AND THEREFORE COULD NOT DETERMINE THE CAUSE OF THE FAULT REPORTED BY THE CUSTOMER. 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 AUTOFEED HUMIDIFICATION CHAMBERS STATE THE FOLLOWING: "SET APPROPRIATE VENTILATOR ALARMS." "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 VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT AN MR290 AUTOFEED HUMIDIFICATION CHAMBER CAUSED AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT TO FAIL THE VENTILATOR LEAK TEST. THIS OCCURRED PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT AN MR290 AUTOFEED HUMIDIFICATION CHAMBER CAUSED AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT TO FAIL THE VENTILATOR LEAK TEST. THIS OCCURRED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202919 VENTED AUTOFEED CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 130912

    Patients

    Seq Age Sex Outcome Treatment
    1 FPH RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRC| FPH RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRC