BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3951468 · Received July 22, 2014

    Report

    Report Number
    9611451-2014-00644
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 24, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    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 HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. IT WAS VISUALLY INSPECTED AND SUBSEQUENTLY CONNECTED TO A WATER BAG TO TEST FOR LEAK. RESULTS: VISUAL INSPECTION REVEALED TWO HOLES IN THE FILTER OF THE BAG SPIKE VENT. UPON CONNECTING TO A WATER BAG, WATER DROPLETS BEGAN TO FORM AT THE SPIKE VENT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 140204. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE DAMAGE OBSERVED ON THE RETURNED BAG SPIKE VENT. ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. ANY CHAMBER THAT FAILS IS REJECTED. THIS SUGGESTS THAT THE DAMAGE TO THE BAG SPIKE VENT OCCURRED AFTER THE CHAMBER WAS RELEASED FOR DISTRIBUTION. 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." THE HOSPITAL STAFF CORRECTLY CHECKED THE MR290 PRIOR TO PATIENT USE. THIS IS IN LINE WITH OUR USER INSTRUCTIONS.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT WATER LEAKED FROM THE VENT VALVE OF THE BAG SPIKE ON AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER.THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428513 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 1402040304

    Patients

    Seq Age Sex Outcome Treatment
    1