BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2592891 · Received May 30, 2012

    Report

    Report Number
    9611451-2012-00356
    Event Type
    Malfunction
    Date Received
    May 30, 2012
    Date of Event
    April 25, 2012
    Report Date
    May 9, 2012
    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 MR290 CHAMBER WAS RETURNED TO FPH IN (B)(4) FOR VISUAL INSPECTION. RESULTS: VISUAL INSPECTION REVEALED THAT THERE WAS A BREAK IN THE FEEDSET TUBING OF THE RETURNED CHAMBER. THE BREAK WAS LOCATED AT THE CONNECTION TO THE WATER BAG SPIKE. THE SURFACE OF THE BREAK WAS ROUGH (NOT SMOOTHLY CUT). A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 110421. CONCLUSION: THE DAMAGE APPEARED TO BE CAUSED BY THE TUBE BEING PULLED AWAY FROM THE SPIKE, POSSIBLY DUE TO THE FEEDSET BEING CAUGHT OR UNDER TENSION. 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 DAMAGE OCCURRED 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." OUR MONITORING AND TRENDING OF COMPLAINTS INVOLVING BROKEN OR DAMAGED WATER FEEDSET TUBES IN MR290 CHAMBERS HAS A RATE OF OCCURRENCE OF (B)(4) DEVICES PER MILLION SOLD WORLDWIDE IN THE LAST YEAR TO THE END OF APRIL 2012.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT WATER LEAKED AT THE CONNECTION BETWEEN THE WATER FEEDSET TUBE AND SPIKE OF AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER AFTER TWO WEEKS OF USE. IT WAS ALSO REPORTED THAT THE NURSE MAY HAVE PULLED AWAY THE WATER FEEDSET TUBE. 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 110421

    Patients

    Seq Age Sex Outcome Treatment
    1