BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2955936 · Received February 11, 2013

    Report

    Report Number
    9611451-2013-00089
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 27, 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 RECEIVED AT OUR (B)(4) FACILITY FOR EVALUATION. THE CHAMBER AND WATER FEEDSET WERE BOTH VISUALLY INSPECTED AND PERFORMANCE TESTED. RESULTS: NO PHYSICAL DAMAGE WAS OBSERVED TO THE RETURNED CHAMBER OR THE WATER FEEDSET TUBE. SUFFICIENT GLUE WAS FOUND AT THE SPIKE AND FEEDSET TUBE CONNECTION AND THE BOND WAS SECURE. WHEN TESTED UNDER NORMAL CONDITIONS, NO LEAK WAS FOUND AT THE FEEDSET TUBE/SPIKE CONNECTION. THE CHAMBER WAS THEN TESTED BY PUTTING THE FEEDSET TUBE UNDER TENSION AND A DROP OF WATER BEGAN TO BUILD AT THE CONNECTION BETWEEN THE FEEDSET TUBE AND WATER BAG SPIKE. CONCLUSION: OUR INVESTIGATION CONFIRMED THAT BOTH THE CHAMBER AND THE WATER FEEDSET WERE FUNCTIONING CORRECTLY WITH NO LEAK UNDER NORMAL OPERATING CONDITIONS. HOWEVER, IT APPEARS THAT THE CUSTOMER HAD SUBJECTED THE TUBING TO TENSION, POSSIBLY BY RAISING THE WATER BAG TOO HIGH AND THIS HAD CAUSED THE FEEDESET TUBING TO LEAK AT THE SPIKE. ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. THE USER INSTRUCTIONS THAT ACCOMPANY THE MR290 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." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE WATER FEEDSET TUBE OF AN MR290 AUTOFEED HUMIDIFICATION CHAMBER LEAKED AT THE CONNECTION OF THE TUBE AND THE BAG SPIKE AFTER TWO DAYS OF PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58035 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 1204240105

    Patients

    Seq Age Sex Outcome Treatment
    1