BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3372205 · Received September 26, 2013

    Report

    Report Number
    9611451-2013-00734
    Event Type
    Malfunction
    Date Received
    September 26, 2013
    Date of Event
    July 1, 2013
    Report Date
    August 28, 2013
    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) WHERE IT WAS VISUALLY INSPECTED FOR THE REPORTED DAMAGE. RESULTS: THE COMPLAINT MR290V CHAMBER WAS RETURNED WITH A BROKEN BAG SPIKE. THE TIP OF THE SPIKE WAS BROKEN. THE SURFACE OF THE BREAK WAS ROUGH (NOT SMOOTHLY CUT). A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 120412. CONCLUSION: BASED ON THE INSPECTION OF THE RETURNED MR290V CHAMBER, THE BAG SPIKE WAS MOST LIKELY SUBJECTED TO EXCESSIVE FORCE. ALL CHAMBERS ARE PRESSURE TESTED BEFORE AND VISUALLY INSPECTED BEFORE THEY LEAVE THE PRODUCTION LINE, ANY BROKEN BAG SPIKES WOULD BE IDENTIFIED DURING THIS PROCESS. ANY CHAMBER THAT FAILS IS REJECTED. THIS SUGGESTS THAT THE DAMAGE TO THE BAG SPIKE 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."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT WATER WAS LEAKING FROM THE CONNECTION PART OF THE WATER FEEDSET TUBE AND THE BAG SPIKE ON AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER. THIS WAS FOUND AFTER A FEW DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486608 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 1204120304

    Patients

    Seq Age Sex Outcome Treatment
    1 RT200 ADULT DUAL-HEATED BREATHING CIRCUIT